Roche obtains FDA blessing for Gavreto

Adult patients with a certain type of non-small cell lung cancer will soon have a new treatment.

The Food and Drug Administration has approved Roche's Gavreto (pralsetinib).

The drug is indicated for the treatment of adults with metastatic rearranged during transfection fusion-positive non-small cell lung cancer as detected by an FDA approved test.

Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations. It is jointly commercialized by Roche Group’s Genentech unit, and Blueprint Medicines.

"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, Roche’s chief medical officer and head of global product development. “We remain committed to finding personalized treatment options for people with cancer based on specific genomic or molecular alterations, and we look forward to partnering with Blueprint Medicines to further explore the potential of Gavreto across multiple RET-altered tumor types.”