Mirati Therapeutics’ Krazati receives positive opinion in NSLC from CHMP

Mirati Therapeutics announced that following a re-examination procedure, the company has received a positive opinion from the European Medicine Agency’s – EMA – Committee for Medicinal Products for Human Use – CHMP – on Krazati as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer – NSCLC – and disease progression after at least one prior systemic therapy. The FDA provided Krazati Accelerated Approval, allowing for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on surrogate endpoints. Krazati was also granted a conditional marketing authorization by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency on November 3. Adagrasib continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC, colorectal cancer, and pancreatic cancer.