FDA Approves 1st Immunotherapy Breast Cancer Drug

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Advanced Breast Cancer and Your Job

FDA Approves 1st Immunotherapy Breast Cancer Drug

The U.S. Food and Drug Administration has given its blessing to the first immunotherapy regimen for breast cancer.

The combination of immunotherapy (Tecentriq) and chemotherapy (Abraxane) was given accelerated approval for triple-negative breast cancer that is locally advanced or has spread, cannot be surgically removed, and has cells that have a protein called PD-L1, CNN reported.

A study published last October in the New England Journal of Medicine found that median progression-free survival (length of time a patient's cancer does not worsen) was 7.4 months among patients who received the combination therapy, compared with 4.8 months among those who received chemotherapy with a placebo, the FDA said Friday.

The study was funded by Genentech Inc., the maker of Tecentriq.

"This is the first time immunotherapy has worked in such a difficult to treat cancer, and is a huge step forward for these breast cancer patients," study author Dr. Peter Schmid, from Queen Mary University of London, said in a statement last October, CNN reported.

The accelerated approval is just the start, noted Dr. Otis Brawley, professor of oncology and epidemiology at Johns Hopkins University.

"The FDA has approved it based on progression-free survival with the hope that later on … data will show that the treatment actually makes women live longer," Brawley told CNN.

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