The US Food and Drug Administration (FDA) has granted accelerated approval to selpercatinib (Retevmo) in 40-mg and 80-mg capsules for adults with locally advanced or metastatic RET fusion-positive solid tumors that have progressed during or following systemic treatment, or for patients for whom there are no good alternative treatments.
In 2020, selpercatinib received accelerated approval for lung and thyroid RET-positive tumors; that approval transitioned to a regular approval for non–small cell lung cancer on September 21. The latest approval expands the drug label to include an array of RET-positive tumor types, including pancreatic and colorectal cancers.
The approval was based on data from the phase 1/2 LIBRETTO-001 trial, which evaluated 41 patients with RET fusion-positive tumors. Thirty-seven patients (90%) had received prior systemic therapy, with almost one third receiving three or more. Primary efficacy measures were overall response rate and duration of response.
Among the 41 patients, the overall response rate was 44%, with a duration of response of 24.5 months. Additionally, for 67% of patients, results lasted at least 6 months.
“In the LIBRETTO-001 trial, selpercatinib demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” said Vivek Subbiah, MD, co-investigator for the trial, said in a press release. “These data and FDA approval of the tumor-agnostic indication underscore the importance of routine, comprehensive genomic testing for patients across a wide variety of tumor types.”
The most common cancers in the study were pancreatic adenocarcinoma (27%), colorectal cancer (24%), and salivary cancer (10%).
The recommended selpercatinib dose, based on body weight, is 120 mg orally twice daily for people who weigh <110 pounds or 160 mg orally twice daily for who weigh ≥110 pounds.
The most common adverse reactions were edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.
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