Bristol Myers Squibb announced today that the U.S. Food and Drug Administration has granted accelerated approval for KRAZATI® in combination with cetuximab as a targeted treatment for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), identified by an FDA-approved test, who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This approval is based on the objective response rate (ORR) and duration of response (DOR) observed in clinical trials, and continued approval is contingent upon further confirmation in additional studies.

“This approval marks a significant advancement for patients with CRC harboring a KRASG12C mutation, a subgroup that has traditionally faced treatment challenges,” said Dr. Rona Yaeger, Gastrointestinal Oncologist & Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center. “KRAZATI in combination with cetuximab provides a promising new option for these patients whose tumors have not responded adequately to prior therapies.”

The FDA's decision was supported by data from the Phase 1/2 KRYSTAL-1 study, which demonstrated a 34% objective response rate with KRAZATI plus cetuximab in heavily pretreated CRC patients with KRASG12C mutations. The median duration of response was 5.8 months. Compared to current late-line treatments, which typically yield response rates of 1-6%, this combination represents a significant therapeutic option for this patient population.

KRAZATI, an irreversible KRASG12C inhibitor with a long half-life and specific pharmacokinetic profile, is also approved for KRASG12C-mutated non-small cell lung cancer (NSCLC). Its approval for CRC underscores its potential across different cancer types harboring this mutation.

Safety considerations include gastrointestinal adverse reactions, QTc interval prolongation, hepatotoxicity, and interstitial lung disease/pneumonitis. These risks necessitate vigilant monitoring and management during treatment.

Bristol Myers Squibb, highlighted the significance of expanding treatment options for cancer patients. She expressed the company’s commitment to advancing oncology therapies and improving outcomes through ongoing research and development.

KRAZATI's approval in CRC reflects Bristol Myers Squibb's dedication to addressing unmet needs in cancer care, leveraging innovative therapies like KRAZATI to enhance patient outcomes and quality of life.

 

Source: businesswire.com

Report Abuse