New Genentech Oncology Drug Gavreto Approved by FDA
Gavreto is the sixth FDA-approved lung cancer therapy in the Roche portfolio
The U.S. Food and Drug Administration (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.
Brand marketing and market access strategy for Gavreto
Genentech is partnering with Gavreto’s innovator 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.
Blueprint gets clinical and commercial support to escalate its ability to create and introduce novel therapies to the marketplace more effectively. Roche has the managed care and oncology sector clinical and business savvy to optimally position Gavreto with clinicians and payers.
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 that patients and oncologists will benefit from,
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 Gavreto is the second therapy Blueprint has launched this 2020.
The first drug, Ayvakyt (avapritinib), was approved in January 2020. It is indicated for the treatment of adults with unresectable or metastatic platelet-derived growth factor receptor alpha (PDGFRA) Exon 18 mutant gastrointestinal stromal tumors (GIST).
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 and 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.
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