FDA grants priority review to Roche's breast cancer drug
Key points
- Roche, the world's biggest maker of cancer drugs, said U.S. health regulators granted a priority review to its experimental breast cancer drug TDM-1, expediting the review process for the marketing application of the drug.
- Food and Drug Administration will announce its decision on the marketing approval by February 26, the Swiss drugmaker said.
- The FDA grants priority reviews to medicines that are considered potentially significant therapeutic advancements over existing therapies.
- Roche said its marketing application for the drug was accepted by European regulators.
Roche, the world's biggest maker of cancer drugs, said U.S. health regulators granted a priority review to its experimental breast cancer drug TDM-1, expediting the review process for the marketing application of the drug.
The U.S. Food and Drug Administration will announce its decision on the marketing approval by February 26, the Swiss drugmaker said.
The FDA grants priority reviews to medicines that are considered potentially significant therapeutic advancements over existing therapies.
Roche said its marketing application for the drug was accepted by European regulators.
TDM-1, or trastuzumab emtansine, is being developed with ImmunoGen, using ImmunoGen's targeted antibody payload delivery technology.
Roche said in late-August that the drug significantly extended the lives of women with an aggressive type of breast cancer, compared with those receiving the standard drug cocktail.
(Reporting By Pallavi Ail in Bangalore; Editing by Maju Samuel)
###
Reuters
Written and revised by
Gerald Hurowitz, M.D.
Our doctors write and review articles for accuracy and keep them up to date.
health.am provides general information, not medical advice. Always consult a qualified health professional about your own health.
Explore health topics
More in this topic
Cancer →
GuideNew method for better treatment of breast cancer
A new study shows that a novel imaging-based method for defining appropriateness of breast cancer treatment is as accurate as the current standard-of-care and could reduce the need for invasive tissue sampling. The…
31 December 2015
NewsT cells that recognize HER2 teceptor may prevent HER2+ breast cancer recurrence
Recurrence of HER2-positive breast cancer after treatment may be due to a specific and possibly cancer-induced weakness in the patient's immune system - a weakness that in principle could be corrected with a…
31 December 2015
NewsNew breast cancer drug may be effective against other types of cancer
Palbociclib, a new oral drug whose efficacy in combating breast cancer has been demonstrated alone and in combination with endocrine therapy, also has potential to combat other types of cancer, according to a literature…
30 December 2015
