Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer

             Basel, 7 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto ™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. 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 may 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 commerci alised by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the US and will be commercialised by Roche outside of the US, excluding Greater China*.“The FDA approval of Gavreto for RET fusion-positive non-small cell lung cancer is an important step towards our goal of providing an effective treatment option for every person diagnosed with lung cancer, no matter how rare or hard-to-treat their type of disease,” said Levi Garraway, M.D., Ph.D ., Roche’s Chief Medical Officer and Head of Global Product Development. “We remain committed to finding personalised treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news