(RTTNews) – Roche (RHHBY) said the United States Food and Drug Administration or FDA has approved Gavreto for the treatment of adults with metastatic rearranged during transfection or RET fusion-positive non-small cell lung cancer as detected by an FDA approved test.
The company noted that this indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication might be contingent upon verification and description of clinical benefit in a confirmatory trial.
Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. It is jointly commercialised by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the US and would be commercialised by Roche outside of the US, excluding Greater China.
Gavreto is now the sixth FDA-approved medicine in Roche’s portfolio of treatments for lung cancer, the company said.
The FDA has also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer, and is expected to make a decision on approval by 28 February 2021.
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