The FDA looks at Carvykti and Abecma and agrees they can both be Bob Beamon long jumpers!

The FDA looks at Carvykti and Abecma and agrees they can both be Bob Beamon long jumpers!

A couple of weeks back I wrote on the good fortune of Carvykti in Europe.  Its marketing authorisation had been approved by EMA’s CHMP to move from fourth line to second line treatment for patients with relapsed and refractory multiple myeloma (RRMM), this huge leap in the approved treatment algorithm being analogous to the spectacular Bob Beamon long jump.  But Carvykti’s European good fortune has until now been unreciprocated in the US; and in the parlance of the long jump event, we’ve all been looking again and again at the video evidence of this jump and the red flag for a foul seems to be waving in our face.  What’s the problem and who will adjudicate on whether to give it a white flag of ”good to go” or a red flag of ”foul”?  All this came to a head last Friday when the FDA hauled the makers of Carvykti (Janssen) and Abecma (BMS) before the austere FDA ODAC (Oncologic Drug Advisory Committee).  ODAC had set aside an all-day meeting for Friday the 15th March 2024 to decide on how to manage both Carvykti and Abecma; I bet it felt like judgment day and would have been scary.  To be fair, ODAC had been very clear about how it would conduct the 15th March meeting:  11 external experts had been invited and will look at the clinical data for Carvykti (CARTITUDE-4) and Abecma (KarMMA-3), specifically on overall survival.  And to be fair, the discussions are very complex.  Just look at this –  a conclusion on overall survival based simply by looking at the Kaplan-Meier curves can be different depending on when you pick your time on the curve.  So, patients on either Abecma and Carvykti were dying earlier (0-15 months) than their corresponding counterparts on standard-of-care.  Sure, there is a switchover around 11-15 months when patients on Abecma or Carvykti then survive longer.  The uncomfortable question of course is ‘What’s causing patients on Abecma or Carvykti to die earlier?’  Uncomfortable question and no easy answers here. In the event, ODAC voted 11-0 unanimously for Carvykti and a good 8-3 for Abecma.  So, where are we on the leaderboard?  Although this has to be officially confirmed by the FDA, it looks like Carvykti has moved from fifth to second line treatment and Abecma has moved from fifth to third line treatment; a good result for both Janssen and BMS. And the flag stays white!!  Bob Beamon lives!

What this shows us is that weighing up the benefits of new and improved drugs can be very, very challenging and nothing is straightforward.  But it’s to the FDA and ODAC’s credit that they are looking at all angles and are prepared to look at the evidence where it really matters-  the clinical data. But maybe the FDA would also be looking over the pond to how Europe is doing with Carvykti, now that it has moved up the ladder from fourth to second line treatment.  For sure, one strand of discussion during the 15th March 2024 ODAC meeting was how optimal was the disease control whilst waiting for the opportunity to unleash either Abecma or Carvykti?  Did that wait contribute to some of the early deaths?  Comparing the data from these new approved lines may eventually provide the answers but for the moment, there is a huge sigh of relief.  I’m certainly relieved the ominously named KarMMA-3 study did NOT live up to its name!

READ THE ARTICLE – https://www.fda.gov/advisory-committees/advisory-committee-calendar/march-15-2024-meeting-oncologic-drugs-advisory-committee-meeting-announcement-03152024

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