Genentech reveals submission of sBLA to FDA for Tecentriq-Avastin
Category: #health  By Pankaj Singh  Date: 2020-01-27
  • share
  • Twitter
  • Facebook
  • LinkedIn

Genentech reveals submission of sBLA to FDA for Tecentriq-Avastin

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

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Pankaj Singh    

Pankaj Singh

With an experience as an insurance underwriter and a freelance writer under his belt, Pankaj Singh boasts of quite some expertise in the field of content creation. A qualified Post Graduate in Management, Pankaj has also completed a detailed course in Digital Marketin...

Read More

More News By Pankaj Singh

Toyota and ENEOS team up to develop hydrogen fuel-cell system in Japan
Toyota and ENEOS team up to develop hydrogen fuel-cell system in Japan
By Pankaj Singh

Japanese automotive giant, Toyota has reportedly tapped Japanese oil & energy corporation, ENEOS, to explore the field of hydrogen-based power to help with the development of a hydrogen fuel-cell system that would power Woven City, Japan’s ...

KPI Global secures 12.5 MW captive solar project from Anupam Rasayan
KPI Global secures 12.5 MW captive solar project from Anupam Rasayan
By Pankaj Singh

Gujarats leading solar power generating company, KPI Global, has recently announced receiving an order for building a 12.5 megawatts solar project under the captive power producer capacity from Surat-headquartered Anupam Rasayan India. It has been r...

Adverum Biotechnologies announces new data from OPTIC Phase 1 trial
Adverum Biotechnologies announces new data from OPTIC Phase 1 trial
By Pankaj Singh

Adverum Biotechnologies, a California based biotech company, has reportedly announced new clinical data from the OPTIC Phase 1 with dose ranging clinical stage trial of gene therapy intravitreal injection namely ADVM-022. The OPTIC trial has enrolle...