FDA Approves Gavreto for Metastatic Non-Small Cell Lung Cancer Subset

FDA Approves Gavreto for Metastatic Non-Small Cell Lung Cancer Subset

September 5, 2020

The Food and Drug Administration approves Gavreto for treatment of patients with metastatic, RET fusion-positive non-small cell lung cancer.

The Food and Drug Administration (FDA) approved and granted priority review to Gavreto (pralsetinib) for the treatment of patients with metastatic, RET fusion-positive non-small cell lung cancer (NSCLC), according to Genentech, the co-manufacturer of the drug.

“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 Dr. Levi Garraway, Genentech’s chief medical officer and head of Global Product Development, in a statement.

The approval was based off findings from the phase 1/2 ARROW study, that showed that Gaverto had durable responses in patients with RET fusion-positive NSCLC, regardless of whether or not they had previous therapy or RET fusion partner or central nervous system involvement.

A total of 57% of patients on the study responded to treatment. In the 87 people who were previously treated with platinum-based chemotherapy, 5.7% of patients had a complete response, meaning that they had no detectable traces of cancer. In the 27 study participants who did not undergo previous treatment, 70% responded and 11% had a complete response.

The most common side effects were fatigue, constipation, musculoskeletal pain and increased blood pressure.

About 1% to 2% of patients with NSCLC have RET-activating fusions, which could drive cancers in the lungs and medullary thyroid. Currently, there are few treatment options for this patient population, so it is important that patients use FDA-approved tests to see if they are eligible for treatment with Gavreto.

“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,” Garraway said.


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