NEW YORK – The US Food and Drug Administration on Wednesday granted full approval for Roche and Blueprint Medicines' Gavreto (pralsetinib) for patients with RET fusion-positive non-small cell lung cancer (NSCLC).
The FDA initially granted accelerated approval to Gavreto in this patient population in September 2020. The approval was based on overall response rates and duration of responses observed among 114 locally advanced or metastatic RET fusion-positive NSCLC patients on the Phase I/II ARROW trial. Now that additional data are available for 123 more patients followed over two years, the agency has decided to convert the accelerated approval to a regular approval.
In tandem with the initial accelerated approval, the FDA approved Thermo Fisher Scientific's Oncomine platform, which evaluates 23 genes associated with lung cancer, as a companion diagnostic to identify NSCLC patients with RET fusions who are eligible for Gavreto.
At this time, Gavreto is still a joint product of Blueprint Medicines and Roche subsidiary Genentech. However, the firms said in February that Roche would discontinue the collaboration for strategic reasons, and that Blueprint Medicines would accordingly regain full rights to the drug in February 2024. The deals exclude greater China, where CStone Pharmaceuticals owns the rights to Gavreto.