Mirati Therapeutics, a clinical-stage targeted oncology company announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRAS mutation who have received at least one prior systemic therapy. The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022.

The adagrasib NDA is being reviewed by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. In addition, the application is being reviewed under the FDA Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRAS mutation who have received at least one prior systemic therapy.

"The acceptance of our NDA for adagrasib is a significant step forward in Mirati's ongoing efforts to advance innovative, differentiated treatment options for patients with KRAS cancers," said Charles Baum, MD, Ph.D.,president, founder and head of research and development, Mirati Therapeutics, "We look forward to working with the FDA during their review of our application and potentially provide a novel option for patients with non-small cell lung cancer."