As Blueprint Medicines braces itself for a future without a major Roche collaboration, the Massachusetts biotech is pulling its RET inhibitor from certain markets and chopping several cancer drug candidates in a prioritization exercise.
Genentech and Blueprint Medicines scored a full FDA approval on Wednesday for Gavreto’s use in a small subset of non-small cell lung cancer patients, nearly three years after celebrating an initial win via the accelerated approval pathway.
Roche`s Gavreto (pralsetinib) Receives Approval in Europe
Blueprint Medicines said its partner Roche will withdraw Gavreto from use in the US for advanced RET-mutant medullary thyroid cancer as it was not feasible for the Roche unit to pursue the drug for full approval, as reported in Yahoo News.
The US indication for pralsetinib (Gavreto) in the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy has been voluntarily withdrawn by Genentech, according to a Securities and Exchange Commission filing from Blueprint Medicines.1
Roche is sending Gavreto back to Blueprint Medicines two and half years after the Swiss pharma paid $775 million up front to in-license the RET inhibitor. Shortly after the deal, the drug scored an FDA approval in non-small cell lung cancer bearing an abnormality in the RET gene.
Pralsetinib achieves tissue-agnostic benefits for patients with RET gene fusions
Roche's Biologic Gavreto (Pralsetinib) Receives Approval in Europe
Basel, 19 November 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today nannounced that the European Commission (EC) has granted conditional nmarketing authorisation for Gavreto® (pralsetinib) as a monotherapy for nthe treatment of adults with rearranged during transfection (RET) nfusion-positive advanced non-small cell lung cancer (NSCLC) not npreviously treated with a RET inhibitor. Gavreto is the first and only nprecision medicine approved in the European Union (EU) for the nfirst-line treatment of people with RET fusion-positive advanced NSCLC.1
CAMBRIDGE, Mass., Oct. 28, 2021 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ:BPMC) today reported financial results and provided a business update for the third quarter ended September 30, 2021.