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

Hyundai supports Teslas appeal for lowering EV import duties in India
Hyundai supports Teslas appeal for lowering EV import duties in India
By Pankaj Singh

India's second-largest automaker, Hyundai Motor India has recently backed Tesla's proposal for lower import duties on electric vehicles. In a statement, Hyundai said that any drop in import duties will be a big help to automakers to generate ...

Unacademy takes over live game streaming platform Rheo TV
Unacademy takes over live game streaming platform Rheo TV
By Pankaj Singh

Unacademy, an Indian educational technology company, has recently announced the purchase of Rheo TV, a live game streaming platform focused on making professional game streaming a mainstream career choice in India. Launched in August 2019, Rheo...

Byju's acquires Epic to strengthen footprint in North America
Byju's acquires Epic to strengthen footprint in North America
By Pankaj Singh

Byju's, a major Ed-tech company based in India, has reportedly taken over Epic, a US-based digital reading platform for kids, in a $500 million deal, with plans to enter the lucrative international market. The acquisition comes over three months...