The FDA has approved KRAZATI (adagrasib) in combination with cetuximab as a treatment for locally advanced or metastatic colorectal cancer (CRC) in adult patients with a KRASG12C mutation. This approval is based on the Phase 1/2 KRYSTAL-1 study, which showed a 34% objective response rate in pretreated patients with KRASG12C-mutated CRC.

KRAZATI is the first KRASG12C inhibitor approved by the FDA for a cancer type beyond non-small cell lung cancer. Its approval is a significant advance for patients with KRASG12C-mutated CRC, as current late-line standard-of-care options provide limited response rates.

The approval is based on results from cohorts of the KRYSTAL-1 study, which evaluated KRAZATI combined with cetuximab in heavily pretreated CRC patients with a KRASG12C mutation. The study met its primary endpoint, demonstrating a confirmed objective response rate of 34% in patients receiving KRAZATI with cetuximab. All responses were partial responses, and the median duration of response was 5.8 months.

KRAZATI is associated with certain warnings and precautions, including gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease/pneumonitis.

Bristol Myers Squibb’s senior vice president of U.S. Oncology and Hematology, Wendy Short Bartie, highlighted the significance of KRAZATI’s approval by indicating that this is an important milestone for BMS and the patients they serve as they deliver on our commitment to provide innovative medicines for cancer.

The FDA previously granted breakthrough therapy designation for KRAZATI in combination with cetuximab for patients with KRASG12C-mutated advanced CRC whose cancer has progressed following prior treatment with certain chemotherapy and an anti-EGFR therapy.

Source link: http://www.businesswire.com/news/home/20240621519236/en/Bristol-Myers-Squibb-Announces-U.S.-FDA-Accelerated-Approval-of-KRAZATI%C2%AE-adagrasib-in-Combination-with-Cetuximab-for-Adult-Patients-with-Previously-Treated-KRAS-G12C-Mutated-Locally-Advanced-or-Metastatic-Colorectal-Cancer-CRC

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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.