Both firms decided to voluntarily withdraw the US RET-mutant MTC indication following consultation with the FDA, as the confirmatory late-stage trial could not be activated to fulfil the post-marketing requirement
Roche’s site in New York, US. (Credit: F. Hoffmann-La Roche Ltd)
Roche Group, in partnership with Blueprint Medicines, is withdrawing Gavreto (pralsetinib) from use in the US for the treatment of a type of thyroid cancer as it is not feasible now for the company to pursue the drug for full approval.
Gavreto was approved in the US to treat adult and paediatric patients aged 12 years and more with advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) who need systemic therapy.
Gavreto is a once-daily, oral precision medicine that intends to selectively target RET alterations, including fusions and mutations, irrespective of the tissue origin.
The approval was granted under the US Food and Drug Administration’s (FDA’s) accelerated approval programme in December 2020.
Roche was expecting a full approval upon demonstration of clinical benefit in the confirmatory Phase 3 randomised AcceleRET-MTC study.
The trial was assessing the drug versus the standard of care in RET-mutant MTC.
Both firms decided to voluntarily withdraw the US RET-mutant MTC indication following consultation with the FDA, as the confirmatory late-stage trial could not be activated to fulfil the post-marketing requirement.
This decision has nothing to do with Gavreto’s effectiveness or safety, and it has no bearing on the drug’s other US-approved uses for non-small cell lung cancer and thyroid carcinoma with RET fusions, Roche said.
In the upcoming years, Roche and Blueprint Medicines will collaborate with the FDA to finish the withdrawal procedure and inform US healthcare professionals about the move.
Furthermore, the pharmaceutical major said that US patients who need systemic medication and are being treated with Gavreto for advanced or metastatic RET-mutant MTC should talk to their doctor about their treatment choices.
The medicine was jointly developed and marketed by Genentech, a wholly owned member of the Roche Group, and Blueprint Medicines in the US through a deal in 2020.
Earlier this year, Roche halted its partnership deal with Blueprint Medicines for Gavreto.