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Wednesday, May 10, 2017 6:40:48 PM
ZURICH (Reuters) - Roche's Tecentriq immuno-oncology drug failed a late-stage follow-up trial against advanced bladder cancer, the Swiss drugmaker said on Wednesday, raising questions about whether regulators could scale back their approval of the medicine.
Roche, the world's biggest maker of cancer drugs, had won fast-track approval last May in the United States for Tecentriq against bladder cancer but full approval hinged on further trials.
Roche said a phase III IMvigor211 study that evaluated the drug in people with locally advanced or metastatic urothelial cancer whose disease progressed during or after treatment with chemotherapy "did not meet its primary endpoint of overall survival compared to chemotherapy."
The Swiss company's shares fell nearly 2 percent.
Roche said it was sticking by Tecentriq.
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