Briefing documents from the FDA suggest that they accept the arguments laid forth by the i2TEAMM initiative and would accept MRD neg as an intermediate clinical endpoint to support AA fda.gov/media/177652/d…

Tune in to FDA discussion on MRD as a surrogate end point in Myeloma

youtube.com/watch?v=pooME9…

Things are about to get interesting- that’s for sure! Great news that Carvykti approved for second line and beyond! Who should get in second line is a big question - Will be a nuanced discussion!
businesswire.com/news/home/2024…

Excited to speak at the UChicagoCancerCenter Development Therapeutics Conference in a few weeks with a terrific lineup of speakers!

Ben Derman Rajat Thawani Joseph W. Franses MD-PhD Dan Olson Toyosi Odenike

…lopmentaltherapeutics.squarespace.com/agenda

ODAC vote: 8 yes and 3 no in favor of ide-cel to move up in lines of therapy.
Surprising based on the level of data that was presented in my opinion.
I think if PFS1 + PFS2 for both arms were shown, we would see it parallels OS signal.

Committee asked for information on Restricted Mean Survival Time - FDA had not performed analysis but sponsor was ready to go with that

J&J provides granular information re: early deaths in cilta-cel arm, which was primarily driven by deaths before infusion (9) OR deaths after infusion (5) among patients who had early prog & received cilta-cel immediately thereafter. The latter group had high early mortality rate