Madeleine Armstrong
@ByMadeleineA
Senior reporter at @ApexOnco; cat lover; Croydon Harrier
$REPL Replimune Receives Complete Response Letter from FDA for RP1 Biologics License Application for the Treatment of Advanced Melanoma ir.replimune.com/news-releases/…
Can anyone explain the $SCLP.L release to me, please?
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 @raffcolo
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.
Here we go: $PFE just went into ph3 with Kat6 clinicaltrials.gov/study/NCT07062… $OLMA
$ATRA refiles Ebvallo, but it's only due a $40m milestone now, down from $60m. Via @ApexOnco oncologypipeline.com/apexonco/atara…
When is a complete response not actually a complete response? Ask $INKT. Via @ApexOnco -> oncologypipeline.com/apexonco/node/… $AGEN
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
$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 @PDRennert
FWIW, the CRLs in FDA's newly released list concerning oncology drugs (excl generics) are for: - penpulimab - torpialimab $CHRS - Fotivda - Trodelvy $GILD - Vyloy $ALPMF
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.
Wow... The FDA just posted an archive of Complete Response Letters from 2020-2024 open.fda.gov/apis/other/app…
Ichnos Glenmark's BCMA x CD38 bispecific ISB 2001 was covered by @ByMadeleineA at #ASCO25. Today licensed to $ABBV for $700m up front $JNJ oncologypipeline.com/apexonco/asco-…
A study of $BNTX & $RHHBY's neoantigen project autogene cevumeran has quietly gone on hold oncologypipeline.com/apexonco/more-…
$GMAB stops a mystery project. GEN1078 is gone, but what did it hit? Via @ApexOnco oncologypipeline.com/apexonco/genma…
