Roche's Tecentriq wins
fast FDA review in tough-to-treat breast cancer
Send a link to a friend
[November 13, 2018]
By John Miller
ZURICH (Reuters) - Swiss drugmaker Roche
said on Tuesday its Tecentriq medicine will get a speedy review by U.S.
regulators in a tough-to-treat form of breast cancer, as it seeks to be
the first company to have its immunotherapy win approval in this
Roche said the U.S. Food and Drug Administration (FDA) gave priority
review to Tecentriq with the chemotherapy Abraxane for initial
treatment of people with metastatic triple-negative breast cancer
whose tumors test positive for a protein, called PD-L1, that helps
them avoid immune system detection.
With the accelerated review, Roche expects a decision by March 12.
"People need more options for this type of breast cancer, which is
particularly difficult to treat," said Sandra Horning, Roche's chief
medical officer, in a statement.
With sales of Tecentriq trailing immunotherapies from Merck and
Bristol-Myers Squibb in the main form of lung cancer, Roche is
seeking to be first-to-market in smaller but still-lucrative
Triple-negative tumors, which affect 15 percent of breast cancer
patients, offer just such an opportunity, though Roche has won the
FDA's priority review in just a subset of patients - the roughly 40
percent of patients in its study whose tumors had high levels of
[to top of second column]
For them, interim overall survival data released at a medical
conference in Germany last month showed they lived a median of 25
months, compared to just 15.5 months for the patients getting only
For all 902 patients in Roche's study - including those whose tumors
did not express high levels of PD-L1 - the benefit was
less-pronounced: Those getting the Tecentriq cocktail lived a median
21.3 months, so far, compared to 17.6 months for those on
chemotherapy, Roche reported.
(Reporting by John Miller; Editing by Gopakumar Warrier)
[© 2018 Thomson Reuters. All rights
Copyright 2018 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
Thompson Reuters is solely responsible for this content.