Roche’s sBLA for Tecentriq-based combination accepted by FDA

Roche has announced that the US Food and Drug Administration has accepted its supplemental Biologics License Application for Tecentriq in combination with Abraxane and carboplatin for the first-line treatment of people with metastatic non-squamous non-small cell lung cancer who do not have EGFR or ALK genomic tumour aberrations. It is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival and progression-free survival in first-line treatment. The interim analysis showed that Tecentriq plus chemotherapy helped people live significantly longer compared with chemotherapy alone (18.6 months compared with 13.9 months). It also significantly reduced the risk of disease worsening or death compared with chemotherapy alone (7 months compared with 5.5 months).

Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche, said: “We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible. Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”