On Aug. 27, 2021, Genentech announced that it is voluntarily withdrawing the breast cancer indication from the immunotherapy medicine Tecentriq (chemical name: atezolizumab) in the United States.
The withdrawal only applies to breast cancer treatment and doesn’t affect other approved indications for Tecentriq. The withdrawal also doesn’t affect the European Commission’s approval of Tecentriq to treat metastatic PD-L1-positive breast cancer.
How was Tecentriq used?
In March 2019, the U.S. Food and Drug Administration (FDA) granted Tecentriq accelerated approval to be used in combination with the chemotherapy medicine Abraxane (chemical name: albumin-bound or nab-paclitaxel) to treat unresectable locally advanced or metastatic triple-negative, PD-L1-positive breast cancer. Unresectable means the cancer can’t be removed with surgery.
Tecentriq was the first immunotherapy medicine approved to treat breast cancer.
Why did Genentech withdraw the breast cancer indication?
According to Genentech’s media release, the FDA based its accelerated approval of Tecentriq for breast cancer on results from the IMpassion130 study. The study showed that the combination of Tecentriq and Abraxane offered better progression-free survival and overall survival than Abraxane alone for people diagnosed with locally advanced or metastatic triple-negative breast cancer who had not been treated yet for advanced-stage disease.
Progression-free survival is how long the people lived without the cancer growing. Overall survival is how long the people lived whether or not the cancer grew.
Still, follow-up time for the IMpassion130 study was only about a year. The FDA had said that continued approval of Tecentriq to treat breast cancer would be based on results from the IMpassion131 study. The IMpassion131 study had a similar design to the IMpassion130 study, but used the chemotherapy medicine Taxol (chemical name: paclitaxel) instead of Abraxane. The researchers wanted to know if adding Tecentriq to Taxol would improve progression-free survival and overall survival. The results showed no difference in progression-free survival between people who received a combination of Taxol and Tecentriq and people who received Taxol alone. The study also showed that more people who received Taxol alone were alive after 2 years than people who received a combination of Taxol and Tecentriq. So the objectives of the study were not met.
Genentech said that because of recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval for Tecentriq to treat breast cancer.
“This led to the difficult decision to voluntarily withdraw the U.S. mTNBC [metastatic triple-negative breast cancer] indication,” the company said in its statement.
What this means for you
If you are currently receiving a combination of Tecentriq and Abraxane for advanced-stage triple-negative breast cancer, you will be able to continue your treatment. But you should talk to your doctor about other possible treatments that would be right for your unique situation.
If you or your doctor have questions or concerns about Tecentriq coverage, reimbursement, or out-of-pocket costs, please call the Genentech Patient Resource Center at 877-436-3683 for help.
Written by: Jamie DePolo, senior editor
Reviewed by: Brian Wojciechowski, M.D., medical adviser
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