FDA Approvals, News & UpdatesLung Cancer

Gavreto Second Drug FDA Approved for Patients with Metastatic Lung Cancer and RET Fusions

November 2020 – Lung Cancer

On September 4, 2020, the FDA accelerated the approval of Gavreto (pralsetinib; from Blueprint Medicines and Genentech), an oral RET inhibitor, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC), the most common type of lung cancer, and RET fusions (genomic alterations), as detected by an FDA-approved test.

RET fusions and mutations are key causes in many types of cancer, including NSCLC and thyroid cancer. In May 2020, the FDA approved the first RET inhibitor Retevmo (selpercatinib) for patients with metastatic NSCLC and RET fusions or mutations (as well as for patients with metastatic thyroid cancer).

Gavreto is the second RET inhibitor approved by the FDA for patients with metastatic NSCLC and RET fusions or mutations. The FDA is also considering Gavreto as a potential treatment for metastatic thyroid cancer and RET fusions.

About 1% to 2% of people with NSCLC have RET fusions. Biomarker testing for RET fusions is the most effective way to identify people who are eligible for treatment with Gavreto.

“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, MD, PhD, Chief Medical Officer and Head of Global Product Development at Genentech. “We remain committed to finding personalized treatment options for people with cancer based on specific genomic or molecular alterations.”

The FDA approved Gavreto for patients with NSCLC and RET fusions based on the results of the early-phase ARROW clinical trial, the first study that is evaluating the safety and efficacy of Gavreto in patients with NSCLC or thyroid cancer and RET fusions or mutations.

Among the 87 patients with NSCLC who have previously received chemotherapy, the overall response rate with Gavreto was 57%, which included some (5.7%) patients who had a complete response (no sign of cancer) to this treatment.

The average length of response has not been reached yet, meaning that in many of the patients, the tumor is still responding to treatment with Gavreto. In the 27 people in the study who had not received previous chemotherapy, the response rate was even better (70%), including 11% of patients who had a complete response to treatment.

The most common side effects with this targeted therapy were fatigue, constipation, musculoskeletal pain, and elevated blood pressure.

Blueprint Medicines is offering a patient support program—YourBlueprint program—to provide financial assistance for eligible patients who are prescribed Gavreto and have a hard time paying for this medication.

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Last modified: November 20, 2020

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