FDA grants breakthrough therapy designation to adagrasib for lung cancer subset
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The FDA granted breakthrough therapy designation to adagrasib for the treatment of patients with KRAS G12C-mutated non-small cell lung cancer who previously received systemic therapy.
Adagrasib (MRTX849, Mirati Therapeutics, Inc.) is a highly selective and potent oral small-molecule inhibitor of KRAS G12C. The agent is optimized to sustain target inhibition, which is important for treatment because data show the KRAS G12C protein regenerates every 24 to 48 hours.
Preliminary results of the registrational phase 1/phase 2 KRYSTAL-01 trial, which includes patients with advanced NSCLC that progressed following treatment with immunotherapy and/or chemotherapy, supported this decision.
The agent has also demonstrated responses as a single agent in NSCLC, colorectal cancer, pancreatic cancer and other solid tumors with KRAS G12C mutations, and it is currently being evaluated in combination with other anticancer agents for advanced solid tumors.
“We are pleased to receive this breakthrough therapy designation for adagrasib, which emphasizes the significant need for new treatment options for patients with lung cancer who harbor the KRAS G12C mutation,” Charles M. Baum, MD, PhD, president and CEO of Mirati Therapeutics, said in a company-issued press release. “We look forward to submitting a new drug application for adagrasib in the second half of this year and further advancing adagrasib across a broad development plan with the goal of improving clinical outcomes in patients with KRAS G12C-mutated cancers."
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