Roche withdraws Tecentriq for treating type of breast cancer in US
New Delhi: Roche Holding AG has decided to withdraw its immunotherapy Tecentriq as a treatment for a type of breast cancer in the United States, the drugmaker said on Thursday following a consultation with the Food and Drug Administration.
The drug received accelerated approval in 2019 to treat inoperable, locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1, a protein that may help the cancer avoid detection by the immune system.
But it failed last year to deliver positive follow-up data required by the regulator.
In April, an FDA panel that reviewed cancer drugs that are granted accelerated approval but have failed to show clinical benefit in confirmatory trials, however, voted in favor of keeping Tecentriq in the market.
Since then Bristol Myers Squibb, Merck and AstraZeneca have pulled out their treatments for other types of cancers due to a lack of benefit seen in confirmatory trials.
Earlier this year, Roche had withdrawn the drug from use in treating bladder cancer in the United States. Outside the country, it will continue to be available for the breast cancer indication.
Tecentriq is also approved to treat non-small cell lung cancer, small cell lung cancer and liver cancer and brought in sales of 2.7 billion Swiss francs ($2.96 billion) in 2020.
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