FDA approves Retevmo for lung cancer, thyroid cancer subsets
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The FDA approved selpercatinib for the treatment of patients with one of three types of tumors that have RET alterations.
The approval applies to use of selpercatinib (Retevmo, Eli Lilly) for adults with RET fusion-positive non-small cell lung cancer that has spread; advanced RET fusion-positive medullary thyroid cancer or medullary thyroid cancer that has spread among patients aged 12 years and older who require systemic therapy; and advanced RET fusion-positive thyroid cancer among patients aged 12 years and older that requires systemic therapy and has stopped responding to radioactive iodine therapy or is not appropriate for radioactive iodine therapy.
Selpercatinib, a kinase inhibitor, is the first therapy approved specifically for patients with cancer who have 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,” Richard Pazdur, MD, 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, said in a press release. “The FDA is committed to reviewing treatments like Retevmo that are targeted to specific subsets of patients with cancer.”
The FDA based the approval on results of a trial that involved patients with each of the three types of tumors for which the agent is indicated.
Patients received selpercatinib dosed at 160 mg orally twice daily until disease progression or unacceptable toxicity. Major efficacy outcomes included overall response rate and duration of response.
The most common adverse events associated with selpercatinib included increased aspartate aminotransferase and alanine aminotransferase levels, increased blood sugar, decreased white blood cell count, decreased albumin in the blood, decreased calcium in the blood, dry mouth, diarrhea, increased creatinine, increased alkaline phosphatase, hypertension, fatigue, swelling in the body or limbs, low blood platelet count, increased cholesterol, rash, constipation and decreased sodium in the blood.