FDA Approves Gavreto for Metastatic Non-Small Cell Lung Cancer

FDA ApprovedThe Food and Drug Administration (FDA) has approved Gavreto (pralsetinib) for treatment of patients with metastatic non-small cell lung cancer (NSCLC). Blueprint Medicines Corporation is a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy. Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. It has been approved for treatment of adult patients with metastatic rearranged during transfection as detected by an FDA approved test. It is designed to selectively and potently inhibit RET alterations that drive many cancer types.

Jeff Albers, Chief Executive Officer of Blueprint Medicines said, “GAVRETO is the second breakthrough therapy discovered by Blueprint Medicines that has received FDA approval in 2020, less than 10 years since the company started operations. This progress reflects the power of our scientific platform, our focus on delivering transformative outcomes to patients and our urgency to address important medical needs.”

Gavreto has received approval by FDA upon verification and description of clinical benefit in a confirmatory trial. In 87 patients previously treated with platinum-based chemotherapy, the overall response rate was 57% with a 5.7% complete response rate. In 27 treatment-naïve patients who were ineligible for platinum-based chemotherapy, the overall response rate was 70% with an 11% complete response rate and median duration of response was 9 months. The approval is based on data from Phase 1/2 arrow clinical trial, which showed efficacy for Gavreto in patients. This approval represents an important advance with the potential to change standards of care for lung cancer patients.

Blueprint Medicines and Genentech plans to make Gavreto available in the US within a week. It will be available in 100mg dose strength and the recommended dose is 400mg once daily.

The information shared in this blog is for educational purposes only. If you face any symptoms, you should contact your healthcare practitioner immediately.

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