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RET fusion and mutation are key disease factors in many cancer types, including NSCLC and thyroid myelin cancer.
in NSCLC, RET fusion accounts for about 1-2% of all patients.
, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved Gawreto™ (pralsetinib) for the treatment of metastasis RET fusion positive non-small cell lung cancer (NSCLC) patients.
approval is supported by I/II ARROW study data.
I/II ARROW study showed that Gavreto produced a lasting clinical response in patients with RET fusion-positive NSCLC, regardless of the central nervous system.
Gawreto showed a total remission rate (ORR) of 57% and complete remission (CR) of 5.7% in 87 patients who had previously been treated with platinum chemotherapy.
in 27 untreated patients with non-small cell lung cancer, the ORR was 70% and the CR rate was 11%.
most common adverse reactions were fatigue, constipation, musculoskeletal pain and high blood pressure.
"We remain committed to finding individual treatment options for cancer patients based on specific genomic or molecular changes, and we look forward to working with Blueprint Medicines to further explore Gavireto's potential in a variety of RET-changed tumor types," said Dr. Levi Garraway, chief medical officer and head of global product development at genentech.
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