FDA accepts application for license to supplementary biologics from gene Tecentriq

today, Roche's Genentechcompany,(http:// announcedthat the u.SFDA(http://has accepted the company's application for a supplementary biologic license (sBLAB) for Tecentriq (sBLAb) for use in combination with chemotherapy (caplatinum and epophilis) as a first-line treatment for a wide range of small cell lung cancer (ES-SCC)The FDA also qualifies the application for priority review and is expected to make a decision on approval by March 18, 2019About Tecentriq
Tecentriq is an anti-PD-L1 antibody developed by Roche that, by blocking the binding of PD-L1 to PD-1 and B7.1 receptors, is an immunocheckpoint inhibitor that reactivates T cells, prompting them to kill tumor cellsIt has been approved by the FDA as a second-line therapy for patients with metastatic non-small cell lung cancer (NSCLC)The studythe results of this sBLA are based on the(http://of phase 3 clinicaltrials called IMpower133In this multicenter, randomized double-blind, placebo-controlled study, 403 ES-SCLC patients were treated with tecentriq and chemotherapy combination therapy, or a combination of placebo-chemotherapy combination therapy results showed that tecentriq and chemotherapy combination therapy reached the common primary end of the trial In the intended treatment group, the total survival of patients significantly increased (OS is 12.3 months, control group is 10.3 months; p-0.0069) Tecentriq combined with chemotherapy also significantly reduces the risk of disease progression and death in patients The patient had no progressive rebirth (PFS) of 5.2 months and the control group was 4.3 months (HR -0.77; 95% CI: 0.62-0.96; p-0.017)