On February 20, Bristol-Myers Squibb (BMS) announced that the FDA has accepted the supplemental New Drug Application (sNDA) for Adagrasib (brand name: Krazati) for use in combination with cetuximab to treat patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).The proposed PDUFA date is June 21, 2024.This sBLA is mainly based on the positive results of the Phase I/II KRYSTAL-1 study. The study is aOpen-label, Multicenter, Multiple Expansion Cohort ClinicalTest, evaluatedAdagrasibEfficacy of single-agent or combination with other anticancer therapies in treating patients with advanced solid tumors harboring KRAS G12C mutations. The primary endpoint of the Phase II portion is the objective response rate (ORR).The results showed that in a cohort of 76 CRC patients who received treatment,Adagrasib + Cetuximab Group andThe ORR of patients in the Adagrasib monotherapy group was 46% (13/28) and 19% (8/43), respectively. The median duration of response (DOR) was 7.6 months and 4.3 months, and the median progression-free survival (PFS) was 6.9 months and 5.6 months, respectively.In terms of safety,AdagraSIB'sWell tolerated.Adagrasib+CetuximabGroupAndThe proportions of Grade 3 or 4 treatment-related adverse events (TRAEs) reported in the Adagrasib monotherapy group were 16% and 34%, respectively. No patients in either group experienced Grade 5 adverse events (AEs).Adagrasib isMirati's KRAS G12C inhibitor, which was approved for the first time in the United States in December 2022, is used for second-line treatment of patients withKRAS G12CPatients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mutations. In October 2023, Bristol-Myers Squibb (BMS) acquired for a total deal value of $4.8 billion.Mirati has obtained ownership of this product.Copyright © 2024 PHARMCUBE. All Rights Reserved.
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