Gavreto Indication for RET-Mutant Medullary Thyroid Cancer Withdrawn

Genentech, in partnership with Blueprint Medicines, has voluntarily withdrawn the US indication of Gavreto^® (pralsetinib) for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who require systemic therapy.

Gavreto was granted accelerated approval for this indication in December 2020 based on data from the phase 1/2 ARROW study (ClinicalTrials.gov Identifier: NCT03037385). A conversion to full approval was contingent upon demonstration of clinical benefit in the phase 3 AcceleRET MTC study (ClinicalTrials.gov Identifier: NCT04760288).

Following a discussion with the Food and Drug Administration (FDA), it was decided that the indication would be withdrawn as the confirmatory trial “could not be activated to fulfill the postmarketing requirement,” according to the Companies.

This action does not affect the other approved indications for Gavreto. Patients who are being treated with Gavreto for RET-mutant MTC should be informed of the withdrawal and be provided with other care options.