TheFinalCD
4 months ago
For those who are curious why $VSTM is down 60% on premarket, being 50% yesterday afterhours, despite positive RAMP 205 data (High ORR)
$VSTM 12 patients experienced treatment emergent serious adverse events, 11 patients with grade β₯3 pic.twitter.com/pY34tS6maD— Swat (@SwatOptions) May 24, 2024
For those who are curious why $VSTM is down 60% on premarket, being 50% yesterday afterhours, despite positive RAMP 205 data (High ORR)β
Today Company announce that they will submit BLA for combo treatment only for a mutant subgroup, which significantly reduces the TAM
π $XBI https://t.co/Au1lEsh0qU pic.twitter.com/LzSvNS1T7n— Dogtor (@Dogtor01416800) May 24, 2024
DrHarleyboy
2 years ago
Regulatory Update Following Type B FDA Meeting on LGSOC Program
A recent FDA meeting was held to discuss the encouraging results to date of the ongoing RAMP 201 trial evaluating avutometinib ± defactinib among patients with recurrent LGSOC, confirm the go forward treatment regimen selection and discuss the regulatory path forward. The combination of avutometinib with defactinib has been selected vs monotherapy as the go forward treatment in all recurrent LGSOC regardless of KRAS status, acknowledging the demonstrated contribution of defactinib.
The Company intends to include mature data from RAMP 201, the Verastem sponsored clinical trial, and the FRAME study, led by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust to potentially support filing for accelerated approval. Both studies are evaluating avutometinib and defactinib in patients with recurrent LGSOC. The Company is in ongoing discussions with the FDA on the confirmatory study and plans to provide an update after agreement with the FDA. Continued enrollment in the combination arm of RAMP 201 is planned to expand the clinical experience in anticipation of initiation of a confirmatory study.
βWe appreciate the productive and ongoing discussions with the FDA regarding the progress of our LGSOC program, including the alignment around key next steps as part of our breakthrough therapy designation,β said Brian Stuglik, CEO of Verastem Oncology. βWith the encouraging results of the RAMP 201 Part A interim analysis and the FRAME study, we will work expeditiously to prepare to file for an accelerated approval that encompasses the totality of the data from both trials as well as progress on the confirmatory study.β
https://investor.verastem.com/news-releases/news-release-details/verastem-oncology-announces-positive-data-and-regulatory-update