Mirati’s Krazati (adagrasib) Receives the US FDA’s Breakthrough Therapy Designation for the Treatment of Advanced KRAS-Mutated Colorectal Cancer
Shots:
- The US FDA has granted Breakthrough Therapy Designation to adagrasib in combination with cetuximab for KRASG12C- mutated, advanced CRC whose cancer has progressed following prior treatment with CT & anti-VEGF therapy
- The designation was based on the P-Ib cohort of the P-Ib/II (KRYSTAL-1) trial evaluating adagrasib as monotx. or combined with cetuximab. The combination therapy showed ORR (46%); m-DoR of 7.6mos. and an m-PFS of 6.9mos. The safety profile was consistent with prior reported results, grade 3 or 4 TRAEs (34%) who received adagrasib monotx. & 16% in combination with no grade 5 TRAEs
- The combination therapy is being studied in an ongoing P-III trial for KRASG12C-mutated CRC. Adagrasib also received the BTD from the US FDA for NSCLC harboring KRASG12C- mutation
Ref: prnewswire | Image: Mirati
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.