September 7, 2020

The U.S. FDA has approved Gavreto™ (pralsetinib), manufactured by Roche, to treat adults diagnosed with metastatic rearranged-during-transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

NSCLC is the most common form of lung cancer in the United States and a leading cause of cancer death. Of the patients who develop NSCLC, an estimated 1-2% also have RET fusion – a genetic alteration that drives tumor development and can also cause resistance to NSCLC treatment. Gavreto works by targeting and inhibiting the activity of RET fusions.

In a clinical study, Gavreto delivered an overall response rate (ORR) of 57% and a complete response rate (CRR) of 5.7% in the patients whose NSCLC was previously treated with platinum-based chemotherapy. For patients who had not received prior treatment for NSCLC, the ORR was 70% and the CRR was 11%.

Recommended dosing is 400mg taken by mouth once daily on an empty stomach. Patients should not consume food for at least two hours before and one hour after taking Gavreto.

Gavreto is available at a wholesale acquisition cost (WAC) of $19,250 per month.

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