Shots:
- This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advanced to the planned PDUFA of Jun 30, 2025 will be available in the US within a week as a co-pack.
- Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200mg, BID) in above pts (n=57) dosed for first 3wks. of 4wk. cycle, which showed cORR of 44% per BICR & mDoR ranging from 3.3 to 31.1mos.
- Regimen is being assessed in P-III (RAMP 301) trial (vs CT) for LGSOC ± KRAS mutation & P-Ib/II (RAMP 205) trial with CT for 1L metastatic pancreatic cancer; P-I/II (RAMP 203) trial assessed the regimen ± defactinib in therapy-naïve & experienced KRAS G12C mutant NSCLC
Ref: Businesswire| Image: Verastem Oncology
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