MedImmune and AstraZeneca plc (ADR)(NYSE:AZN) have disclosed that an sBLA – supplemental Biologics License Application has been accepted for Imfinzi by the Food and Drug Administration. Imfinzi is used to treat patients suffering from unresectable NSCLC – non-small cell lung cancer in situations where the patient has undergone chemoradiation therapy which is platinum-based and where the disease has not shown any progress. A Priority Review status has thus been granted to Imfinzi by the FDA.
The acceptance of the supplemental Biologics License Application by the FDA marks a crucial milestone for the drug since patients require treatment outcomes and options that suit them best. At the moment patients suffering from Stage III lung cancer are under a standard of care that involves active monitoring after definitive chemoradiation.
Phase 3 Pacific trial
Submission of the supplemental Biologics License Application was based on positive data that was obtained during the Phase 3 Pacific trial. Overall survival, the other primary endpoint, is still being evaluated in the trial.
Last month NCCN Clinical Practice Guidelines in Oncology were updated with a view to including Imfinzi as a treatment for patients suffering from unresectable NSCLC in situations where the disease has not progressed after a couple of definitive chemoradiation cycles.
In the United States Imfinzi has been granted accelerated approval as a treatment of patients suffering from metastatic or locally advanced urothelial carcinoma in cases where the disease has progressed following chemotherapy that is platinum-based.
Adverse reactions
During the trial some of the adverse reactions that were noted in the study participants included infections such as osteomyelitis, necrotizing fasciitis and sepsis. About 531 patients which was around 37.6% of the trial participants had infections. In 8 patients the infections they experienced was UTIs. Other adverse reactions were infusion-related and this was observed in about 1.8% of the patients during the trial.
Adverse reactions which led to the discontinuation of Imfinzi were observed in about 3.3% of the trial participants. Serious adverse reactions, on the other hand, happened in about 46% of the patients.
In Tuesday’s trading session shares of AstraZeneca edged up by 0.38% to close the day at $34.78.
