Is Accelerated Approval Successful?

 I know that title is a little click-baity, but I couldn't come up with something short that really captured the complexity of this issue.

The Journal of the American Medical Association published a study last week that looked at treatments that were given Accelerated Approval in the last 10 years. It's called "Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval." The question they sought to answer (and this is quoted from the article) was "What is the clinical benefit of cancer drugs granted accelerated approval, and on what basis are they converted to regular approval?" In other words, how successful are cancer drugs that are given accelerated approval?

A little background, just so we're clear on what all of this means and why its important. The issue has been on my mind a lot lately, as a couple of posts that I wrote last month would indicate.

Most treatments that get approval from the FDA use the results of a phase 3 clinical trial to provide data for the application. Phase 1 trials are usually very small, and their main purpose is to show safety -- they help determine the best dose of the treatment to be effective while being safe. Phase 2 trials focus more on effectiveness, and use a larger number of patients to show that the treatment actually works. Phase 3 trials are, ideally, randomized and double-blind, meaning the new treatment is given to half of the patients in the trial, while the other half gets the old treatment (the "standard of care" -- the one that patients would usually receive). This allows for a direct comparison between the new and the old, so the FDA can see that the new is more effective and/or safer than the old. 

With accelerated approval, the makers of a treatment can apply to have their treatment approved after the phase 2 trial. Accelerated approval is usually given for treatment classes that are brand new, allowing a potentially life-saving treatment to get to patients faster then if they went through the full trial process. This benefits patients because a treatment might get to them sooner. And it certainly benefits the maker of the treatment because they can start making money (and recouping the money they put into research) sooner. 

But part of the deal is that the clinical trial process has to continue. A "confirmatory trial" has to happen to show that the good results from the smaller phase 2 trial will actually hold up over time. If the trial is successful, then the treatment gets full approval. If not, then the treatment is withdrawn.

The JAMA article, then, wants to know just how successful those accelerated approvals are -- how many actually go on to get full approval.

The authors looked back at the 129 cancer treatments that were given accelerated approval by the FDA between 2013 and 2017, and then looked at the 46 of them that had follow-up data after 5 years. The results were not great, in terms of how many showed an improvement in survival or quality of life -- only 20 of the 46 (or 43%).

Despite that, 29 of the 46 (63%) went on to get full approval. Another 10 (22%) were withdrawn, and 7 of the (15%) were still in the confirmatory trial process.

Looking at those 29 that did get full approval, only 7 of them (24%) were shown to improve both overall survival and quality of life. Another 7 improved overall survival but not quality of life, and 6 improved quality of life but not overall survival. The remaining 9 did not improve either one.

Those number are very important, which is why I'm sharing them, but I also have to point out some limitations here. I'm not able to access the full article, so I'm not sure how they measuring "quality of life." Overall survival is easy enough to measure, but quality of life is harder, and I'm not sure every study uses the kinds of patient-reported quality of life measurements that I'm familiar with. I guess that's how they measure safety, looking at the side effects that patients experienced? That would be the standard measurement in a clinical trial. If that;s the case, I really do not like referring to it as "quality of life." That completely ignores a whole lot of things that should be included in a measurement of the quality of life. 

Aside from that, Overall Survival is a complicated measurement, too. There are certainly cancers that are so aggressive that new treatments are successful when they add months to a patient's life. Then there are others, like Follicular Lymphoma, that have OS measured in years. The measurement can be so long that the median OS hasn't been reached in 5 years. That's actually very common in FL treatment trials, which is why they use Progression Free Survival as a measurement instead. So without looking at the full article, I can't tell if they are counting something like that as improving OS or not improving OS.

This is what I meant when I said it was all kind of complex.

Ultimately, though, I'm not sure those details matter.

The authors of the study provide this conclusion: "Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within 5 years of accelerated approval. Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes."

I would hope that any conversation about treatment with an oncologist would include that information, and that any oncologist would take that into consideration before recommending it to a patient. But I also know, based on the kind of enthusiasm that lots of oncologists had for PI3K inhibitors, that they aren't going to wait for full approval before using them, and that even a preliminary OK from the FDA is good enough. And probably should be.

So, I'll ask the question again that I ask in my title -- Is Accelerated Approval Successful? 

By some measures, No, it isn't. If more than half of accelerated approvals don't result in a better experience for patients, then it seems like the system failed. On the other hand, if the goal is to get new improvements to patients more quickly, than it's a success. And if a large number don't get full approval, then that IS a success. Arguably, the system works -- the treatments that aren't doing the job don't last. If the FDA gave them early approval and then just forgot about them, that would be a problem. But the follow-up makes sure that they are as god as the smaller trial showed.

Of course, "success" isn't just about how well the system works. It's about the patients who get the treatments. Every confirmatory trial that failed means a bunch of patients who didn't get the treatment they had hoped for. And that hurts to think about. From what I can tell, a lot of the treatments get accelerated approval because they offer something that available, standard-of-care treatments can't offer. Think about something like a bi-specific. It works on cancer cells in ways that no other treatment works. If the confirmatory trial involves mostly patients who have tried everything else they could, and they have hope for this new thing that might work in a different way, then that's a success. Clinical trials are necessary, and trials need participants. 

It's all so complex. 

In the end, I think Accelerated Approval has its place, and the authors are right -- being fully informed is key to it all. Talk to your oncologist about treatments, about clinical trials, and about anything else that concerns you. (But you knew that already, you smart, informed FL patients....)

Great Debates: Alternatives to CAR-T

There's a really interesting speaker series that happens every year in New York City called "Great Debates and Updates in Hematological Malignancies." Basically, a bunch of famous oncologists get together, two of them pick sides of a debate about blood cancer, each one speaks for a while, some others comment on what they said, and they move on to the next debate.

It's probably a little bit misleading to call them "debates." I'm not sure they really expect there to be winners and losers. It's more like they are exploring together, looking at issues that don't have definite answers, and offering there thoughts. It's really an alternative format for the kinds of "update videos" that I like to post every now and then.

Follicular Lymphoma seems like a natural fit for something like this, since there really aren't any clear answers when it comes to our disease. Usually at ASH or ASCO every year, someone makes a presentation that looks at the last 10 years or so of FL diagnoses in a database, and how the patients were treated. And the treatment choices will be all over the place -- some watch and wait, some Rituxan, some traditional chemo (some of them Bendamustine and some R-CHOP), some R-squared, plus a bunch of treatments in clinical trials. You see what I'm getting at, I'm sure. There is still no clear treatment path for FL that everyone can agree on. That's partly because FL patients present differently, but also because all of those treatments work, so oncologists just go with what they've always used.

So there's lots to debate, if two oncologists are looking to have a friendly debate.

At this year's "Great Debates" (which happened about a week ago), the FL debate feature Dr. Peter Martin of Weill Cornell and Dr. Caron Jacobson or Dana Farber. The debate centered on Relapsed FL and CAR-T. Dr. Martin's presentation was called "CAR-T Cells Should Be Rarely Used in Relapsed Follicular Lymphoma," while Dr. Jacobson's was "CAR-T Cells Should Be More Often Used in Relapsed Follicular Lymphoma." Pretty straightforward.

Unfortunately, I don't have access to Dr. Jacobson's talk, but I do have an interview with Dr. Martin, where he summarizes what he said at "Great Debates." It's an interesting talk, and worth the 5 minutes it takes to view it (or read the transcript, both of which you can find here.)

I'll give you a summary. Dr. Martin's role in this debate is to argue in favor of "all of the other treatments" besides CAR-T, which seems to me to be the easier side to take. But he focuses in particular on 3 treatment options (and remember, these are for relapsed FL, not for first treatment). Traditional chemotherapy is not one of the options -- "we're al moving beyond that," he says.

The first of the three is R-Squared, or Rituxan + Revlimid (also known as Lenalidomide). In its favor is the fact that we have data from two large trials now, so we know a lot about side effects and effectiveness. As he says, R-squared will work for between 2 and 5 years on average, and it's well-tolerated.  A good option.

Second is Tazemetostat, an EZH2 inhibitor. It works especially on B cells, keeping them from growing, which makes it very well-suited to FL. About 20% of patients have a mutation in EZH2 that makes Tazemetostat a very good option, and it has very few serious side effects. For patients who have the particualr mutation, t can be very effective, especially given the low side effects.

Finally, and "most exciting," according to Dr. Martin, are the bi-specifics. He compares them especially to PI3K inhibitors, saying bi-specifics are geared toward the same population as those who tried the PI3K inhibitors, but the bi-specifics are twice as effective. They can be tricky to administer, and their most serious side effect is Cytokine Release Syndrome. But bi-specifics are also (like Rituxan) open to combinations with other treatments, which could increase effectiveness. 

It's interesting to me that this once again comes down to bi-specifics vs. CAR-T, but that's not a surprise.

What's most important is this statement from Dr. Martin: "I think we're at a very fortunate time in the history of follicular lymphoma to have a number of excellent options."

That's absolutely true, and the most important take away from this "great debate." We do have some excellent options, and more likely on the way.

I'm going to keep an eye out for Dr. Jacobson's talk on why CAR-T should be used more often. She's great, and I'm sure it will be worth sharing. 

But for now, we can remember that we have some other options, and they're very good.

Cannabis and Cancer

I saw an article a few days ago that caught my attention. It's from The Guardian, written by an oncologist from Australia, and it's called "Patients keep asking if they should take cannabis for their cancer. The answer is still no."

That title -- with it's "No" at the end -- reminded me of a sign that I saw once in a doctor's office. The doctor was a pain specialist, and I was there with a loved one. The sign said, in big letters, "If you are using marijuana for any reason, WE WILL NOT TREAT YOU!"

Those are both very strong statements from doctors, and they show clearly how against cannabis use some doctors are. 

I remember asking the second doctor (the one I had taken a loved one to see) why he was against marijuana use. "Are you using it?" he asked me and my loved one. "No," we said, which was true. "Good," he replied. And that was the end of the conversation.

That doesn't seem very helpful from a doctor, especially if they have such strong feelings about it. A sign like his should open a conversation, not shut it down. The whole interaction was, unfortunately, pretty typical of this doctor.

The first doctor, the one who wrote the article linked above, is a little less dramatic about the whole thing, and I think her article is worth reading. She also has strong beliefs, but is also clear about why (there is little evidence that cannabis helps with pain, nausea, sleep, or other cancer-related problems, at least in the research that she lays out). But she also links to the ASCO document that came out about a month ago, called "Cannabis and Cannabinoids in Adults With Cancer: ASCO Guideline."

The ASCO recommendation are pretty much what the author has to say, providing a "nonjudgmental" approach to patients, because patient use of cannabis has "outpaced the research." In other words, up to 40% of cancer patients are using it, whatever the research says.

And the problem is that there is so little research. Blame this on marijuana remaining a Schedule I substance in the United States, meaning it is considered to be among the most dangerous, addictive drugs we know. As a Schedule I substance, there are sever limits on the kinds of research tat can be done on it. It's been a catch-22 for a very long time -- there isn't enough research to show that it might have benefits for people, but there can't be more research because it's considered dangerous.

An FDA panel has suggested that it should be moved to a Schedule III substance, but so far that hasn't happened.  

I'm fond of ASCO, as you all probably know, and their guidelines make sense to me. 

There is no evidence that cannabis can cure any type of cancer. That might not be the case if and when it goes through more clinical trials, but for now, there's no evidence. I would never suggest cannabis in any form be used Alternative Medicine -- in place of an approved, tested treatment for cancer. I'm not a fan of Alternative Medicines. 

But Complementary or Integrative Medicine? That's a different story. There is some evidence that some patients do get some benefit from cannabis use, whether for nausea, pain, sleep, anxiety, or other issues. If they get some benefit, and they obtain the cannabis legally, then what's the problem? Even if the positive effects are psychological rather than physical, there's a benefit there. 

I hope oncologists are open to the conversation, and are clear about the ASCO guidelines and what they say -- cannabis is not a cure-all, and it can do some good, but doesn't work for everyone and does have some side effects that need to be considered. You can say that about any substance, and any Integrative practice. 

I can't offer any experience with this -- I've never used cannabis for anything related to cancer. But I'd be very interested to hear about some of your experience, especially if it's used under a doctor's care (and it probably should be, just as your doctor should know about anything you take, from blood pressure meds vitamin D). I'd like to know if it's really as popular as research suggests, and if it really does work for people.

Share your stories if you're up for it.

 

CAR-T 2.0?

A small pharma company announced today that it was submitting an Investigational New Drug (IND) application to the FDA for what they are calling "CAR-T 2.0," a newer, better version of CAR-T (or so they hope).

The treatment is called SynKIR-310, and the phase 1 trial will be patients with relapsed/refractory B-cell Lymphomas, including Diffuse Large B Cell lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, and Marginal Zone Lymphoma.

Their treatment includes a couple of differences when compared to current CAR-T treatments. They call theirs KIR-CAR, the "KIR" being "Killer-Cell Immunoglobin-like Receptors."  These help to regulate a type of immune cell called a Natural Killer (NK) cell. NK cells are a type of lymphocyte, like B cells (which turn cancerous in FL) and T cells (which is what CAR-T uses). NK cells work differently than B and T cells, which need exposure to a threat before they can eliminate them. Basically, B and T cells have to learn that a threat (like a virus or a bacteria) is a threat. NK cells can recognize cells that are damaged by disease (like cancer) and eliminate them, and then send signals to other cells that there is a problem. 

KIR-CAR is also different in that it targets a different type of protein than CAR-T usually does. CAR-T usually attaches itself to the CD19 protein, while KIR-CAR will attach itself to something very similar. 

The upshot of this, if all goes according to plan, is that SynKIR-310 will allow T cells to not have to work as hard as they do with CAR-T, meaning it will be effective longer than current CAR-T is (for some patients, CAR-T is very durable, but for about half, it stops working after a year or so, if it worked at all).

I say "if all goes according to plan" because, of course, this is very new. It has been effective on animal models, but this IND application will mean it will be tried on humans for the first time in a trial. If you follow clinical trials over the long term, you now that a pretty small percentage will ultimately end up in the doctor's office. 

Still, this is worth mentioning because it is a really good example of the kind of innovative research that is happening to make CAR-T even more effective than it is. It would be wonderful if this trial was successful and it moved on to bigger tests. 

Early, but definitely one to keep an eye on. 

Cancer, Royalty, and Minding One's Business

I've been thinking about cancer a lot lately.

That's no surprise. There hasn't been a day in 16+ years that I haven't thought about cancer. It's a side effect of being a cancer patient, as well as a blogger who needs content.

But I'm also keeping an eye on a couple of other folks who both have cancer. They are people that I work with. I've known them for years, though I wouldn't say I'm personally close with them. Their diagnoses have an effect on my job, so they told me about it before they told most people. They also know about my own diagnosis from years back, so I think they trust me to be sensitive about theirs.

Both have been in treatment for several months. I try to check in with them every few weeks. Just an email saying "I'm thinking about you. I hope you're doing OK." 

One of them writes me back with updates -- very detailed updates, sometimes as detailed as a medical chart. This colleague also asks lots of questions, about my treatment, my experiences, my feelings. We don't have the same diagnosis, but cancer patients share a lot of things anyway. As you probably know, it's comforting to have someone else who has been through it all say "Yes, I felt that way too." 

The other colleague doesn't usually respond. When I do get a response, it's not really about the details -- more of a general "Had a doctor's appointment last week and things are going OK." For this colleague, it's the second time around. The cancer was first diagnosed a few years ago, and now it has come back. But the funny thing is, I have no idea what kind of cancer this colleague was diagnosed with. They have never shared it. Unlike the first colleague who gives me a full medical chart of detail, this one has always been very private about their personal life, and they give me almost no detail at all. Not even the type of cancer.

And you know what? That's just fine.

That's what I've been telling myself as I see so much news about the British Royal Family. I'm not a "royal watcher," though I did enjoy watching The Crown. Most of what I read about their situation has come from cancer-related websites. 

In case you don't know what I'm talking about, here's a summary: In January, King Charles announced that he was being treated for an enlarged prostate. About the same time, his daughter-in-law, Princess Catherine, announced that she was having abdominal surgery. Eventually, the King announced that he was diagnosed with cancer. And recently, the Princess also announced that her surgery resulted in a cancer diagnosis.

Neither of them has announced the type of cancer they were diagnosed with. The Princess said she has been in treatment with "preventative chemotherapy," but hasn't said what type. 

And you know what? That's just fine.

I've complained elsewhere that I really wish celebrities would give more detail about their diagnoses. I am particularly annoyed when famous people announce "I have been diagnosed with non-Hodgkin's Lymphoma," and leave it at that. Because then I have to see al of the articles that tell me the survival rates for NHL without being clear that NHL isn't really a disease, but a name for about 60 other diseases, ranging from very slow-growing to incredibly aggressive, to the point where anything you say about "NHL" is meaningless. So I wish celebrities would give us some more detail. I feel like if we have to watch them go through the cancer experience, some of us would like to know just how relevant it is to our lives. If someone famous has Follicular Lymphoma, I want to know how much their very visible diagnosis reflects my own.

And then I very quickly push that out of my head.

Because it's their experience, not mine, and it's none of my business. 

As I said, I'm not a "royal watcher," but I do get a sense of how complicated their situation is. As a royal family, they have a different position than most celebrities. And if The Crown is accurate (and I know it's ultimately fiction), they also are very careful in managing their image, for reasons that may or may not be valid. And of course, Princess Catherine is a young mom, and needs to be mindful of her children and how they are experiencing all of this (I've been there, too -- The Princess is two years older than I was when I was diagnosed, and her kids are all within a year of how old my kids were at the time). 

So The King and The Princess are dealing with cancer while they are also dealing with their responsibilities to their families and their country. I don't envy them.

But in the end, whatever their responsibilities, whatever their decisions, the same thing is true for them as it is for all of us:

There's no right or wrong way to experience cancer.

Even for those of us who might be going around for the second or third time with cancer, it's still a new experience. And there's no playbook for this, no instruction manual, no To Do List. We make it all up as we go along.

And that's OK. 

Even if we look back later on and wish we had done things differently, the decisions we make at the time are the ones we are making based on the information we have and our needs at the time. If we decide to share all of the details with the world -- even starting a blog -- that's great. If we decide to keep it all inside and not share any or all of the details? That's OK too.

As for King Charles and Princess Catherine? They can tell us whatever they want, or keep the details to themselves. In the end, they are cancer patients, separate from their lives as Royals, and their only duty is to themselves and their families.

I hope you are all doing well, and feeling like the decisions you have made have been the right ones. 

Because they have been.

FDA Denies Approval for Bispecific (For Now)

The FDA has denied approval for the bispecific Odronextamab -- for now. In giving the denial, the FDA pointed to problems in the trial, rather than concerns about its safety or effectiveness. 

Some background: Odronextamab is a bispecific, meaning that it works in two parts. It is a monoclonal antibody, like Rituxan. (I keep referring back to Rituxan when I talk about monoclonal antibodies, because it's been around for so long and is so widely used in Follicualr Lymphoma that I assume most readers know what it is.) In fact, it attaches to CD20, the same protein on the surface of B cells that Rituxan attaches to. But as a bispecific, Odronextamab also attaches to a T cell, an immune cell that can help kill off the cancer cell when it comes in close contact with it. If you've been reading the blog for the last year or two, you know that bispecifics are one of those treatments that tend to get oncologists very excited.

Odronextamab (which was known as REGN1979 before it got its official name) was granted accelerated review last October by the FDA. As you may know, accelerated review means the FDA will look at a smaller set of data (maybe from a phase 2 trial instead of a larger phase 3 trial) and make a decision in a shorter amount of time (usually about 6 months instead of about 10 months). They usually grant this faster review because the treatment will provide something that is not currently available to patients, and it will help a larger number of people if they can get access to it sooner.

However, accelerated review is also provisional review. Approval will allow the maker of the treatment to make it available, but they also have to keep up their clinical trials and submit data to show that it really is as safe and effective as it seems in that shorter amount of time. 

For Odronextamab, the original application was based on data from phase 1 and phase 2 trials. The results from those trials were strong. In phase 2 trial, patients with Follicular Lymphoma had an Overall Response of 82% and a Complete Response of 75%. The treatment was durable, with a median duration of response of 20.5 months and median Progression Free Survival was 20 months. Safety was decent, though 100% of the 131 patients with FL experienced side effects, with 78% of them experiencing grade 3 (serious) side effects, including Cytokine Release Syndrome (in over 50% of patients in the trial), low blood cell counts, diarrhea, fever, and joint pain. 

Importantly, the denial of the application is based on numbers of patients, not on concerns about safety or effectiveness. Basically, the FDA wants to see how the treatment works in more patients. They aren't denying the application forever, just until more data can be collected.

Of course, that's not what the maker of Odronextamab wanted to hear. There are actually two types of trials required, one focused on dosing (making sure the optimal amount of the treatment is given) and the other focusing on confirming the results f the earlier trials. The company behind Odronextamab says it is actively recruiting patients for these trials and is working with the FDA to have a new schedule later this year.

A couple of things seem significant to me.

First, this seems like a clear signal that the FDA really is getting more serious about accelerated approvals. With problems coming up after a quick approval, the agency wants to make sure treatments are safe and effective. In this case, they don't seem to be switching to an emphasis on Overall Survival, with all of the complications that would come with it (as William and Peter pointed out in their comments to my post earlier this month). They don't necessarily want new or different data here, just more of it. That seems like a reasonable approach.

Second, this confirms the importance of clinical trials, and patient participation in them. New treatments can't be approved without large trials, and large trials need willing patients. As you meet with your oncologist, add that question to your conversation -- are there clinical trials that would be appropriate for me, if and when I need treatment again? It's important to know what might come next for you, and important to all of us that new treatments have the data that they need to be approved (or not approved, which is just as important).

I'm sure there will be updates about Odronextamab in the very near future -- maybe as soon as a couple of months from now at the ASCO conference. But we'll definitely hear something by the end of the year about what the plans are for trying to get permanent approval.

Drug Name Tournament

Here's a kind of fun item for you Cancer Nerds: the website Fierce Pharma is holding a "drug name tournament" for the next few weeks.

Some background for you first. In the U.S., we are just beginning the period known as "March Madness." College basketball is a big deal to many people in this country, and this week, the NCAA tournament begins. This involves 64 basketball teams that will play each other to determine who the national champion is. (I know it's actually 68 teams, but we're not going to complicate this any more than necessary.) And there are actually two tournaments, one for men's teams and one for women's teams. You can find a decent explanation of it all here.

There are lots of opportunities to get into a "tournament pool" where you have to guess which teams will win in each round of the tournament, all the way to the national champion. There are "office pools" set up among people who work together, and lots of chances to play against strangers online. Participating involves "filling out a bracket," guessing the winner of every game before the first game has even started. Sometimes there is light gambling involved, with the participants putting up a little money and the winner getting all of it. 

It is notoriously difficult to guess every winner of every game in the tournament. This is because of the way the tournament is set up. It doesn't involve the best 64 teams in the country. Instead, some teams get in because they have won their conference or group, and so a few teams are very small and not well known, and no one expects them to win against bigger, better-known teams. But these small teams do occasionally win, bringing up lots of David vs Goliath comparisons. It can be fun to get into a pool, unless your teams lose early.

Because not everyone is basketball fan, there are also lots of alternate "March Madness" tournaments around at this time of year. Everything from best Beyonce songs to best characters from Pride and Prejudice. You're not guessing the winners of games; instead, you're guessing which choices you think will be the more popular in the bracket.

So back to Fierce Pharma. They are holding a "drug name tournament." Last year, they had a tournament where readers picked the best advertising campaigns from pharmaceutical companies. this year, they're going with drug names. They have chosen 64 drugs out of the 92 that were approved by the FDA in 2022 and 2023, and put them into a bracket, NCAA tournament-style.

Their goal isn't to have people choose the "best" drug, but rather to choose the best name. It's more about marketing than effectiveness (since that is Fierce Pharma's focus). In making choices, they'd also like participants to add what they think the drug name sounds like. Fierce Pharma has given their own example for each of the 64 names. (For instance, one of the drugs is Jesduvroq, which is meant to help with low red blood cell counts due to chronic kidney disease. They think Jesduvroq sounds like something you would say "when you hit your finger with a hammer, but it’s in front of your children so you’re trying not to swear.")

For me, as a Cancer Nerd, it all sounds kind of fun. Drug names are always a little strange, though with some very serious work behind them, and this tournament pokes some gentle fun at them. I like that.

And if you're wondering if any Follicular Lymphoma treatments made the cut -- YES! There are two of them.

The first is Lunsumio, the bispecific that is also known as Mosunetuzumab. Fierce Pharma says the name Lunsumio sounds like a Japanese wrestler.

The second is another bispecific, Columvi, also known as Glofitamab. This was approved by the FDA for Diffuse Large B-cell Lymphoma, though it includes DLBCL arising from transformed FL. (There are some additional clinical trials for FL going on as well.) Fierce Pharma says Columvi sounds like an ancient Roman detective. Slightly more creative than their Lunsumio comment.

So good luck to all of you participating in March Madness tournaments, whether it's for basketball or something else.  Let me know if you do well in the Fierce Pharma competition.