New Genentech Oncology Drug Gavreto Approved by FDA
Gavreto is the sixth FDA-approved lung cancer therapy in the Roche portfolio
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
Gavreto was issued granted Breakthrough Therapy Designation for the treatment of RET fusion-positive NSCLC that has progressed following platinum-based chemotherapy and for RET mutation-positive MTC that requires systemic treatment which up to now had no specific therapy options. Available by prescription only, Gavreto is produced in 400mg capsules and taken orally once per day.
More indications for Gavreto may follow
Moving forward, the FDA has issued a Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer. A decision is expected from the FDA by February 28, 2021, and if approved would equip Gavreto with another indication.
Blueprint Medicines has distinctive expertise in protein kinases
Founded in 2008, Blueprint Medicines (NASDAQ: ) focuses on cancer immunotherapy genomically defined cancers and rare diseases. In 2019, Blueprint produced over $66 million in sales. Their revenue production should climb sharply as 2020 so far has rewarded them with two new products.
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
Based in South San Francisco, Genentech was founded in 1976. It was acquired by Roche in 2009 for about $46 billion. Genentech and Roche ((Swiss Exchange: ROG-CH OTCQX: RHHBY) have had an eventful year. Among its many achievements and activities, Roche is a global leader in COVID-19 diagnostics and Genentech launched a new breast cancer drug, Phesgo (pertuzumab, trastuzumab and hyaluronidase–zzxf) in June. Roche’s annual sales in 2019 were about $64 billion. Its deep experience in oncology and other advanced medicine will serve Gavreto well.
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