On September 21, 2022, the FDA approved Retevmo (selpercatinib; from Eli Lilly), a selective RET kinase inhibitor, for the treatment of patients with any locally advanced or metastatic (spreading) solid tumors associated with the RET gene fusion. The solid tumors in the study were pancreatic cancer, soft-tissue sarcoma, bronchial carcinoid, cholangiocarcinoma, colorectal cancer, salivary cancer, breast cancer, ovarian cancer, small intestine cancer, as well as other unknown primary solid cancers.
Retevmo was previously approved for patients with advanced or metastatic thyroid cancer associated with RET fusion and for patients with locally advanced or metastatic non–small-cell lung cancer and RET fusion, as detected by an FDA-approved test.
Also on September 21, the FDA approved the Oncomine Dx Target Test as a companion diagnostic for Retevmo, to identify patients who could benefit from Retevmo therapy.
“Selpercatinib [Retevmo] demonstrated clinically meaningful and durable responses across a variety of tumor types in patients with RET-driven cancers,” said Vivek Subbiah, MD, M.D. Anderson Cancer Center, and a study coinvestigator.
“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,” Dr. Subbiah added.
The approval of Retevmo for any solid tumor with RET fusion was based on results of the multicenter clinical trial of 41 patients with solid tumors (excluding lung cancer and thyroid cancer) associated with RET fusion whose disease progressed during or after systemic therapy or who had no alternative treatment options.
Overall, 44% of the patients responded to Retevmo therapy, and the average duration of response was 2 years (24.5 months).
The most common side effects reported in 25% or more of the patients in this study included edema, diarrhea, fatigue, dry mouth, hypertension, abdominal pain, constipation, rash, nausea, and headache.
