Amgen’s Blincyto has been issued a full approval in the US as a treatment for adults and children with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).
The immunotherapy was granted an accelerated approval in by the US Food and Drug Administration back in 2014, after data showed that, in patients treated with Blincyto (blinatumomab) for at least four weeks via infusion, 32 percent had no evidence of disease for around 6.7 months.
Full clearance now issued by the regulator is in part based on results from the Phase III TOWER study, which found that Blincyto nearly doubled median overall survival over standard of care (SOC) chemotherapy (7.7 months versus four months, respectively).
Safety results among patients who received the drug were comparable to those seen in the earlier studies, the firm noted. The drug’s prescribing information includes a boxed warning for cytokine release syndrome and neurologic toxicities, and it is also under a risk evaluation and mitigation strategy programme.
"Relapsed or refractory ALL is often a lethal disease, with a median overall survival of just four months on standard of care chemotherapy," said Bijal Shah, medical oncologist at the Moffitt Cancer Center in Tampa, Florida.
"As a physician, my goal is to identify treatments that improve response rates in patients with aggressive haematologic malignancies. Blincyto is an option that has been shown to help these high-risk patients fight their disease."
Blincyto is the first single-agent immunotherapy to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor ALL, and the first-and-only FDA-approved CD19-directed CD3 bispecific T cell engager (BiTE) immunotherapy.