Wait.. BIG caveat. These CRL letters are for drugs that were later approved. The really good stuff -- CRLs for drugs not/never approved are not being disclosed.

$ABBV gained an option over Simcere's BCMA x GPRC5D in Jan, now follows up with $700m for Glenmark's BCMA x CD38. Via ApexOnco -> oncologypipeline.com/apexonco/node/… cc Paul D. Rennert

FWIW, the CRLs in FDA's newly released list concerning oncology drugs (excl generics) are for: - penpulimab - torpialimab $CHRS - Fotivda - Trodelvy $GILD - Vyloy $ALPMF

I scoured the FDA's cache of CRLs and found six that relate to novel oncology drugs. Includes first formal disclosure that Akeso's penpulimab got a CRL in 2024. Via ApexOnco -> oncologypipeline.com/apexonco/node/… $AVEO $IMMU $GILD $CHRS $ALPMF $CKPT

When is a complete response not actually a complete response? Ask $INKT. Via ApexOnco -> oncologypipeline.com/apexonco/node/… $AGEN

$ATRA refiles Ebvallo, but it's only due a $40m milestone now, down from $60m. Via ApexOnco oncologypipeline.com/apexonco/atara…

Here we go: $PFE just went into ph3 with Kat6 clinicaltrials.gov/study/NCT07062… $OLMA

Based on the low-key comments from the FDA (nothing like the attacks we've heard at recent adcoms) I see $GSK Blenrep getting positive votes both for Dreamm-7 & 8.

Nerd alert! What do the latest proposed INNs tell us about $MGNX $AZN $BNTX $GSK $IVBXF and other ADCs? Via ApexOnco -> oncologypipeline.com/apexonco/node/… H/t Raffaele Colombo

Can anyone explain the $SCLP.L release to me, please?

$REPL Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma ir.replimune.com/news-releases/…

$EXEL stops Stellar-305 trial of zanzalintinib. My most recent take on this asset, via ApexOnco oncologypipeline.com/apexonco/exeli…