logo
Plus   Neg
Share
Email

FDA Grants Priority Review To Roche's Polatuzumab Vedotin On Lymphoma

Roche (RHHBY) said that the US Food and Drug Administration has accepted the company's Biologics License Application or BLA and granted Priority Review for polatuzumab vedotin in combination with bendamustine plus Rituxan or rituximab or BR for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma or DLBCL. The FDA is expected to make a decision on approval by 19 August 2019.

The BLA is based on results of the GO29365 study, which showed that polatuzumab vedotin plus BR improved median overall survival compared to BR alone (12.4 vs. 4.7 months, HR=0.42; 95% CI 0.24-0.75; exploratory endpoint), in people with R/R DLBCL not eligible for a haematopoietic stem cell transplant.

The study also showed that 40% of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18% of people treated with BR alone achieved a CR (primary endpoint, as measured by positron emission tomography; CR rates assessed by independent review committee). A CR means no cancer could be detected at that time.

Priority Review designation is granted to medicines that the FDA considers to have the potential to provide significant improvements in the safety and effectiveness of the treatment, prevention or diagnosis of a serious disease. Polatuzumab vedotin was also granted Breakthrough Therapy Designation by the FDA and PRIME (PRIority MEdicines) designation by the European Medicines Agency for the treatment of people with R/R DLBCL in 2017.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Amazon is expanding the aircraft fleet of its air cargo network by leasing 12 additional Boeing 767-300 converted cargo aircraft from Air Transport Services Group Inc. This comes amid increased demand for shipments due to the coronavirus pandemic. These aircraft will join Amazon Air's existing fleet of 70 aircraft to bring its total network to more than 80 aircraft. New York's transit agency The Metropolitan Transportation Authority or MTA has pulled its newest subway cars from service after two cars got detached from a moving train. New York City Transit Interim President Sarah Feinberg launched an investigation into the matter. The entire R179 fleet from Canadian company Bombardier Inc. has been pulled until further notice after the incident in Chambers AMC Entertainment Holdings, Inc., the world's largest theatre chain, said it has substantial doubt in its ability to continue its business as theaters across the world remain closed for months now following coronavirus or Covid-19 pandemic. In a regulatory filing, the company said it is "generating effectively no revenue", and that additional capital, if needed, may not be available.
Follow RTT