In September, Roche received FDA approval for 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.
This indication was approved under the FDA’s Accelerated Approval program, based on data from the phase I/II ARROW study. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and mutations.
Genentech and Blueprint Medicines (Blueprint) are partnering to develop and commercialize the product. Their strategic collaboration enables Genentech (Roche) to augment their oncology product portfolio and Blueprint receives clinical and commercial support to increase their ability to develop and introduce products to the marketplace more effectively.
Gavreto is the second therapy Blueprint has launched this year. The first drug, AYVAKIT (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.
Roche can provide national as well as worldwide marketing and sales resources to increase the success of Gavreto following its launch. Roche recorded $6.1 million in net product revenue during the third quarter of 2020 for AYVAKIT.
Blueprint Medicines offers the YourBlueprint program as a patient assistance program for eligible patients who are prescribed Gavreto and AYVAKIT and need financial assistance.
Takeaway: Both Gavreto and AYVAKIT are available through Blueprint’s specialty distribution network and two specialty pharmacies: Biologics by McKesson and PantherRx