- Roche will withdraw its immunotherapy Tecentriq for use in a hard-to-treat form of breast cancer in the U.S., stating Friday it made the decision following negative results in confirmatory testing and after consulting with officials at the Food and Drug Administration.
- Tecentriq was one of three immunotherapies, along with Merck & Co.'s Keytruda and Bristol Myers Squibb's Opdivo, that had certain accelerated approvals come under FDA scrutiny this year because follow-up data did not confirm initial positive data. An FDA advisory committee, however, had voted 7-2 to keep Tecentriq on the market for triple-negative breast cancer.
- The FDA recently gave full approval to Keytruda in triple-negative disease based on data showing the treatment plus chemotherapy could reduce patients' risk of having the cancer return or dying. Roche said it was working with the FDA to find a way to keep Tecentriq on the market in this setting, but "due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval." Other approved indications aren't affected, Roche said.
Triple-negative breast cancer doesn't respond to the hormonal or targeted therapies that have been successful in keeping patients alive and cancer-free for many years, and is viewed as more aggressive than other types of the disease. Drugmakers have for years struggled to come up with better treatments.
Roche, the developer of breast cancer therapies like Herceptin, Kadcyla and Perjeta, sought to prove Tecentriq in triple-negative breast cancer early, gaining an accelerated approval for the disease in 2019. But that OK was conditional based on the success of the IMPASSION-131 study, results from which showed last year that Tecentriq plus chemotherapy didn't keep patients alive and free of disease progression significantly longer than chemotherapy alone.
Under the rules governing accelerated approvals, failure of a drug in a confirmatory trial should lead to withdrawal from the market. Yet in the past, it has rarely happened, due in part to limitations on FDA authority as well as to flexibility offered by the agency to drugmakers.
Facing growing criticism and a series of negative confirmatory findings for immunotherapies, however, the FDA in April convened a three-day a group of independent advisers to review accelerated reviews of Keytruda, Opdivo and Tecentriq in six different settings. After much debate, the expert panel voted in favor of withdrawing only Opdivo in liver cancer and Keytruda in stomach cancer.
Merck and Bristol Myers followed through on those withdrawals, and the latter company also pulled an older drug called Istodax in a type of lymphoma because a confirmatory trial failed. Even before the advisory committee, the companies were examining accelerated approvals and making decisions to withdraw their drugs in some settings, such as Roche's call to pull Tecentriq in bladder cancer and Merck in a type of lung cancer.
Accelerated approvals could draw even sharper scrutiny moving forward, as the inspector general of the Department of Health and Human Services has begun a formal review after the FDA's much-criticized decision to conditionally clear Biogen's drug Aduhelm in Alzheimer's disease.