Adagrasib plus cetuximab receives accelerated approval to treat advanced colorectal cancer
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The FDA has granted accelerated approval to adagrasib with cetuximab for the treatment of KRASG12C -mutated locally advanced or metastatic colorectal cancer, according to a press release from the agency.
The approval was based on results from the KRYSTAL-1 multicenter, single-arm expansion cohort trial, which included 94 patients with KRASG12C-mutated colorectal cancer who had previously been treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based therapy.
The overall response rate of adagrasib (Krazati; Mirati Therapeutics Inc.) plus cetuximab (Erbitux; Imclone) was 34% (95% CI, 25-45) and the median duration of response was 5.8 months (95% CI, 4.2-7.6), according to the release. All responses were partial responses, and 31% of responding patients experienced a duration of response of at least 6 months.
The most common adverse events included rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, cough, dizziness, constipation and peripheral neuropathy, the FDA said.[SV1]
As Healio previously reported, adagrasib is a covalent KRASG12C inhibitor that showed promise alone and in combination with cetuximab for heavily pretreated patients with advanced colorectal cancer with KRASG12C mutations.
The drug was previously granted priority review and breakthrough therapy designation.
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