November 13, 2018 / 6:15 AM / 8 months ago

Roche's Tecentriq wins fast FDA review in tough-to-treat breast cancer

ZURICH, Nov 13 (Reuters) - Roche’s Tecentriq medicine will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer as the Swiss drugmaker seeks to be the first company to have its immunotherapy win approval in this indication.

Roche said the U.S. Food and Drug Administration (FDA) gave priority review to Tecentriq mixed with the chemotherapy Abraxane for initial treatment of people with metastatic triple-negative breast cancer whose tumours test positive for a protein, called PD-L1, that helps them avoid immune system detection.

The FDA’s goal in priority reviews is to complete its work within six months, helping speed up the use of a medicine. (Reporting by John Miller; Editing by Gopakumar Warrier)

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below