Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.
The EC granted the company a full marketing authorisation for the drug based on the overall survival date from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (PH-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
The randomized, active-controlled, open-labelstudy for BLINCYTO showed a ‘superior improvement’ in median OS over standard of care (SOC) chemotherapy. Median OS was 7.7 months (95% CI: 5.6, 9.6) for BLINCYTO compared to four months (95% CI: 2.9, 5.3) for SOC (HR for death=0.71;p=0.012).
For patients treated in first salvage, the median OS was 11.1 months for BLINCYTO versus 5.3 months for SOC (HR=0.6, 95 percent CI: 0.39, 0.91).
Safety results were comparable in patients with the same conditions in the previous Phase 2 BLINCYTO studies, Amgen said.
Senior vice president of translational sciences and oncology at Amgen.David M. Reese said: “BLINCYTO is the first single agent immunotherapy to demonstrate superior overall survival benefit over standard of care.”
He added: “For decades, overall survival has been the gold standard for assessing the efficacy of treatments for blood cancers. The near doubling of median overall survival versus standard of care seen in the TOWER study is groundbreaking and reinforces BLINCYTO as a highly effective ALL therapy, providing physicians with a much needed, efficacious treatment option, potentially offering patients the chance to live longer.”