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Roche, Blueprint Medicines Withdraw Gavreto in RET-Mutant Medullary Thyroid Cancer in US

NEW YORK – Genentech on Friday said it will stop selling the RET inhibitor Gavreto (pralsetinib) in the US as a treatment for RET-mutant advanced medullary thyroid cancer.

Genentech parent firm Roche obtained development and commercialization rights to Gavreto from Blueprint Medicines in a 2020 deal, but earlier this year announced it was ending that partnership and returning rights to Blueprint in 2024.

In a US Securities and Exchange Commission filing, Blueprint said that Genentech, as the new drug application sponsor for Gavreto in the US, has decided after discussing with the US Food and Drug Administration that it will withdraw the medullary thyroid indication from the market and no longer pursue the Phase III AcceleRET-MTC confirmatory clinical trial due to feasibility. According to Blueprint, the withdrawal was not due to any new safety or efficacy issues related to Gavreto.

The FDA in 2020 granted accelerated approval to Gavreto for treating adult and pediatric patients 12 years of age or older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy. The sponsors needed to conduct the AcceleRET-MTC trial to confirm Gavreto's clinical benefit in this setting and convert the accelerated approval to full approval.

The withdrawal is only for the medullary thyroid cancer indication, the companies said. The drug remains on the market for RET fusion-positive thyroid cancer and RET-altered non-small cell lung cancer.

Blueprint noted in the SEC filing that Gavreto's thyroid cancer indication contributes only "a small fraction" of the drug's annual revenues. Blueprint also said that despite Genentech's decision to withdraw this indication, it is still expecting 2023 collaboration revenue in the range of $40 million and $50 million.