RE:How does Accelerated Approval work June 24, 2024 - Bristrol Myers Squibb's KRAS inhibitor has been granted Accelerated Approval as part of a combination treatment for a subset of colorectal cancer (CRC) patients.
The approval is based on results from cohorts of the Phase 1/2 KRYSTAL-1 open-label study which evaluated KRAZATI. The study met its primary endpoint, with a confirmed ORR of 34% (n=94, 95% CI: 25-45) for KRAZATI with cetuximab, all of which were partial responses
The matter of particular interest is that BMS's drug Krazati was approved in combination with another drug, which is the pathway to a approval that ONCY's pelareorep is taking in combination with immune checkpoint inhibitors, bispecifics, ADC and CAR-T therapy, and small molecules like CDK 4/6 and PARP inhibitors.
https://pmlive.com/pharma_news/bristol-myers-squibbs-krazati-combination-granted-fda-accelerated-approval-in-colorectal-cancer/