FDA Announces Second Approval of Gavreto

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New indication focuses on metastatic rearranged during transfection fusion-positive non-small cell lung cancer.

KRAS G12C mutation in non-small cell lung cancer (NSCLC) - closeup view 3d illustration. Generative AI. Image Credit: Adobe Stock Images/Aiden

Image Credit: Adobe Stock Images/Aiden

After previously approving Gavreto (pralsetinib) for non-small cell lung cancer (NSCLC) in late 2020, the FDA has announced an additional approval for metastatic rearranged during transfection (RET) fusion-positive NSCLC. Backed by an FDA-approved test, efficiency was demonstrated in a total of 237 patients with locally advanced or metastatic RET fusion-positive NSCLC. Patients received pralsetinib until disease progression or unacceptable toxicity, according to an FDA press release.

In the same press release, the FDA stated that the recommended pralsetinib dose is 400 mg orally once daily, to be taken on an empty stomach.

Reference: FDA approves pralsetinib for non-small cell lung cancer with RET gene fusions. FDA. August 9, 2023. Accessed August 10, 2023. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pralsetinib-non-small-cell-lung-cancer-ret-gene-fusions

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