Genentech, Inc., a subsidiary of the Roche Group, has reportedly announced the completion of a sBLA (supplemental Biologics License Application) submission to the U.S. FDA (Food and Drug Administration) for Tecentriq ® (atezolizumab) in combination with Avastin ® (bevacizumab) for treating Unresectable HCC (Hepatocellular Carcinoma) patients who did not receive prior systemic therapy.

The FDA is evaluating this application in accordance with the RTOR (Real-Time Oncology Review) pilot program. It intends to explore a more efficient review process to ensure effective and safe treatments are available to patients as soon as possible.

In July 2018, the agency granted Breakthrough Therapy Designation for Tecentriq combined with Avastin for treating HCC based on its ongoing Phase Ib trial outcomes.

Levi Garraway, M.D., Ph.D., CMO and Head of Global Product Development, said that liver cancer is the fastest increasing cause of cancer-related death in the U.S. In the IMbrave150 study, Tecentriq together with Avastin became the first treatment in a decade to enhance overall survival compared to the current standard of care.

Garraway claims that Genetech is pleased that these results are currently being reviewed under the FDA Real-Time Oncology Review pilot program. They are working closely with the agency to bring this potential new treatment option for treating unresectable HCC patients as soon as possible.

For the record, Genentech has a widespread development program for Tecentriq, including several current and planned Phase III clinical trials, across numerous types of genitourinary, lung, breast, skin, gynecological, gastrointestinal, and head & neck cancers. These studies are assessing Tecentriq both alone and in combination with other medications.

Genentech is also developing medicines intending to revolutionize treatments in oncology. The company is presently studying over ten cancer immunotherapy medicines across 70 clinical trials both alone and in combination with other medicines.
 

Source Credit - https://www.gene.com/media/press-releases/14835/2020-01-26/genentech-submits-supplemental-biologics