AstraZeneca PLC’s (LON:AZN) Imfinzi cancer treatment has cleared another regulatory hurdle after the US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) for the treatment of certain lung cancer patients.
Specifically, the application is for the use of Imfinzi in people with stage III unresectable (i.e can’t be removed completely through surgery) non-small cell lung cancer whose disease has not progressed following chemotherapy.
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Astra said the FDA has granted the treatment ‘priority review’ status, adding that the acceptance was an “important milestone” for Imfinzi.
The current standard of care is active monitoring following concurrent sessions of chemoradiation.
“The sBLA submission is based on positive progression-free survival (PFS) data from the Phase III PACIFIC trial. The trial continues to evaluate overall survival (OS), its other primary endpoint,” said the drugmaker this morning.
Results of the PACIFIC trial of Imfinzi, released last month, showed an improvement in progression-free survival by 11 months compared with standard of care in patients with locally-advanced unresectable lung cancer.
Patients treated with the drug also had a lower incidence of metastases, the development of new tumours, than those receiving placebo. The trial is continuing to evaluate the other primary endpoint, overall survival.
Astra shares were up 0.5%, or 23p, to £51.78 in mid-morning trade.