NEW YORK – The European Commission on Friday granted conditional approval to Roche's pralsetinib (Gavreto) for advanced RET fusion-positive non-small cell lung cancer.
The approval is specifically for RET fusion-positive NSCLC patients in the European Union who have not received prior treatment with a RET inhibitor. As a conditional authorization, the approval will require additional confirmatory data from Roche validating pralsetinib's benefit.
The European Commission based its decision to approve pralsetinib on results from the Phase I/II ARROW trial. Among 75 RET fusion-positive NSCLC patients enrolled in the study who had not received any prior treatment, pralsetinib resulted in a 72 percent overall response rate, and the duration of response was not yet reached. Among 136 patients who had received prior treatment with chemotherapy, meanwhile, the drug resulted in a 58.8 percent overall response rate and a 22.3-month median duration of response.
The approval comes on the heels of the US Food and Drug Administration's accelerated approval for the same patient population last year. At the time, the FDA approved Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic to identify eligible patients with RET fusion-positive disease.
Beyond NSCLC, pralsetinib — for which Roche shares commercialization rights with Blueprint Medicines in the US — has US approval for certain RET-altered thyroid cancer patients, too. According to Roche, a European regulatory submission is likewise planned for the thyroid cancer indication.