FDA Approves Adagrasib (Krazati) with Cetuximab for KRAS G12C-Mutated Colorectal Cancer

1. FDA Approval: The FDA granted accelerated approval to adagrasib (Krazati) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
2. Efficacy: The approval was based on the results of the KRYSTAL-1 trial, which showed an overall response rate (ORR) of 34% and a median duration of response (DOR) of 5.8 months.
3. Safety Profile: The most common adverse reactions (≥20%) included rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, dizziness, cough, constipation, and peripheral neuropathy.
4. Competitor: Amgen's Lumakras (sotorasib) is a key competitor to Krazati, and Amgen is seeking approval for Lumakras in the treatment of colorectal cancer.
5. Market Projections: Global sales of Krazati are projected to reach $1.3 billion by 2029, while Lumakras is expected to generate $1 billion in global sales by 2029.