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FDA Grants LOXO-292 Breakthrough Designation for NSCLC, MTC

Silas Inman @silasinman
Published: Wednesday, Sep 05, 2018

 Josh Bilenker, MD

Josh Bilenker, MD
The FDA has granted LOXO-292 a breakthrough therapy designation for the treatment of patients with RET fusion–positive non–small cell lung cancer (NSCLC) or RET-mutant medullary thyroid cancer (MTC), according to Loxo Oncology, the manufacturer of the selective RET inhibitor.

The breakthrough designation is specifically for the treatment of patients with metastatic RET fusion–positive NSCLC who require systemic therapy and have progressed following platinum-based chemotherapy and an anti–PD-1 or anti–PD-L1 therapy; and for the treatment of patients with RET-mutant MTC who require systemic therapy, have progressed following prior treatment, and have no acceptable alternative treatment options.

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