Shots:
- The US FDA has received NDA of bezuclastinib under the RTOR program for the treatment of pts with GIST who were previously treated with imatinib, backed by the P-III (PEAK) trial of bezuclastinib + sunitinib vs sunitinib monotx.
- Trial met its 1EP of improved PFS by 50% (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs 26%, with a mean duration of treatment of >19mos.; full data to be presented by H1’26
- The combination will advance to P-II for treatment-naïve or imatinib-experienced 1L GIST pts with exon 9 mutations this quarter, with NDA filing in AdvSM on track for H1’26; Congent also established FDA-aligned EAPs for eligible US pts with GIST or SM receiving bezuclastinib-based therapies
Ref: Globenewswire | Image: Cogent |Press Release
Related News: Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for NonAdvanced Systemic Mastocytosis (NonAdvSM)
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