Swiss multinational pharmaceutical company, Roche has recently revealed that the U.S. FDA has acknowledged its sBLA (supplemental Biologics License Application) and approved Priority Review for Tecentriq® (atezolizumab) as an initial monotherapy for patients suffering from advanced NSCLC (non-squamous and squamous non-small cell lung cancer) without ALK mutations with elevated PD-L1 expression or EGFR. Reportedly, the FDA is anticipated to come to a decision by June 19, 2020.

According to reliable sources, this sBLA is centered around the findings from the Phase III IMpower110 trial, which demonstrated that Tecentriq monotherapy enhanced OS (overall survival) by 7.1 months when equated to chemotherapy in patients with extreme PD-L1 expression. Tecentriq’s safety profile seemed to be coherent with its known safety profile, with no additional safety signals being detected.

Speaking on the move, Levi Garraway, M.D., Ph.D., Head of Global Product Development and Chief Medical Officer, Roche, said that revisiting the IMpower110 trial, Tecentriq solely established a noteworthy improvement in OS when compared to chemotherapy for newly diagnosed NSCLC patients.

Additionally, the company is closely working with the FDA to release its chemotherapy-free alternative for all NSCLC patients as soon as possible.

Prior to this news, Roche had made headlines when the China National Medical Products Administration (NMPA) granted approval Tecentriq®, in association with chemotherapy ( etoposide and carboplatin), for the initial therapy of patients with ES-SCLC (extensive-stage small cell lung cancer).

Commenting on which, Garraway added that small cell lung cancer is a crucial segment with huge unmet needs in China. Besides, there haven’t been any major advances in this sector until now.

With this consent, Tecentriq would become the first-ever cancer immunotherapy to be accessible in China for the first-line therapy of ES-SCLC. This would come as an important and swift leap for patients, in terms of medical progression, who suffer from this chronic disease.

Source Credit: http://www.globenewswire.com/news-release/2020/02/19/1986747/0/en/FDA-grants-priority-review-to-Roche-s-Tecentriq-monotherapy-as-first-line-treatment-of-certain-people-with-advanced-non-small-cell-lung-cancer.html