The FDA has granted Breakthrough Therapy Designation to adagrasib as a potential treatment for patients with non-small cell lung cancer who harbor the KRASG12C mutation after prior systemic therapy. 

A release from the manufacturer described adagrasib as an oral small-molecule inhibitor of KRASG12C, optimized to sustain target inhibition.  

The designation followed preliminary results from the Phase 1/2 KRYSTAL-01 trial, of patients with advanced NSCLC, previously treated with immunotherapy and/or chemotherapy.  

Studies have shown the drug to have a long half-life, extensive tissue distribution, and is well tolerated, according to the company.  

“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 KRASG12C mutation,” Charles M. Baum, MD, PhD, President and CEO, Mirati Therapeutics, Inc. 

Baum said the company intends to submit a New Drug Application for adagrasib in the second half of the year.  

Evaluation of the drug is ongoing in other clinical trials as part of a combination therapy option for patients with advanced solid tumors, including NSCLC and colorectal cancer, according to the manufacturer. 


By Adam Hochron