Verastem Oncology’s Avutometinib Gains the US FDA’s Orphan Drug Designation to Treat Pancreatic Cancer
Shots:
- The US FDA has granted ODD to avutometinib + defactinib for treating pancreatic cancer. A rolling NDA submission has been initiated for the combination in recurrent LGSOC, to be completed in H2’24, with the US FDA’s decision anticipated in H1’25
- Avutometinib is being assessed under the P-Ib/IIa (RAMP 205) trial for its safety, tolerability & efficacy combined with defactinib & SoC CT (gemcitabine & nab-paclitaxel) in treatment naïve pancreatic cancer patients, with part A finding RP2D for proceeding to part B. 41 patients were treated in 4 dose cohorts
- Interim data (as of May 2024), highlighted at ASCO 2024, showed confirmed PR in 83% of patients at >6mos. follow-up & a single DLT that was cleared after additional patient recruitment in dose level 1; 21/26 patients in all cohorts who had their first scan, experienced a reduced target lesion sum of diameters. Further data anticipated in Q1'25
Ref: Verastem | Image: Verastem
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
