Genentech Launches New Oncology Product: Gavreto
Genentech Launches New Oncology Product: Gavreto
… Genentech expands oncology product portfolio

New Genentech Oncology Drug Gavreto Approved by FDA

Gavreto is the sixth FDA-approved lung cancer therapy in the Roche portfolio

John G. Baresky

The FDA has approved Genentech’s Gavreto (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. Gavreto is an oral selective RET kinase inhibitor.

Genentech is partnering with Blueprint Medicines based in Cambridge, Massachusetts in the development and commercialization of the product. Their strategic collaboration enables Genentech (Roche) to augment their oncology product portfolio and Blueprint gets clinical and commercial support to escalate their ability to develop and introduce products to the marketplace more effectively.

The new product’s review was given a high priority by the FDA so the decision to approve it would be made sooner

More indications for Gavreto may follow

Blueprint Medicines has distinctive expertise in protein kinases

Gavreto is the second therapy Blueprint has launched this year. The first drug, Ayvakyt (avapritinib), was approved in January 2020. It is indicated for the treatment of adults with unresectable or metastatic PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST). Roche can provide them with national as well as worldwide marketing and sales resources to amplify the success of Gavreto following its launch.

Genentech is a wholly-owned business unit of Roche

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