FDA APPROVES FIRST THERAPY FOR PATIENTS WITH LUNG AND THYROID CANCERS WITH A CERTAIN GENETIC MUTATION OR FUSION

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The U.S. Food and Drug Administration (FDA), approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or “rearranged during transfection”). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.

“Innovations in gene-specific therapies continue to advance the practice of medicine at a rapid pace and offer options to patients who previously had few,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.

“The FDA is committed to reviewing treatments like Retevmo that are targeted to specific subsets of patients with cancer.”