Mirati Therapeutics gets FDA breakthrough therapy designation for adagrasib

The company states: "Mirati Therapeutics announced that the FDA has granted BTD to adagrasib in combination with cetuximab in patients with KRASG12C-mutated, advanced CRC whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy. This designation is supported by results from the Phase 1b cohort of the KRYSTAL-1 trial. The FDA program grants BTD to expedite the development and regulatory review of drugs that have demonstrated preliminary clinical evidence of a substantial improvement over available therapy in the treatment of patients with serious diseases on at least one clinically significant endpoint. In addition, today, the NEJM published findings from the ongoing multicohort KRYSTAL-1 Phase 1/2 study evaluating adagrasib as monotherapy or combined with cetuximab in patients with KRASG12C-mutated metastatic colorectal cancer. These data reported promising clinical activity and demonstrated a favorable tolerability profile with reversible adverse events."