FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

发布时间： 2020-05-11 阅读：758次

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May 08, 2020 - Today, the U.S. Food and Drug Administration 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.

Specifically, the cancers that Retevmo is approved to treat include:

Non-small cell lung cancer (NSCLC) that has spread in adults,

Advanced medullary thyroid cancer (MTC) or MTC that has spread, in patients 12 and older who require systemic therapy.

Advanced RET fusion-positive thyroid cancer in those age 12 and older that requires systemic therapy that has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy.

“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.”