(RTTNews) - Takeda (TAK) said that, following discussions with the U.S. Food and Drug Administration, it will voluntarily withdraw its lung cancer drug Exkivity (mobocertinib) from the U.S. The company plans to similarly initiate voluntary withdrawal globally where the drug is approved.
The decision was based on the outcome of the Phase 3 confirmatory trial, which did not meet its primary endpoint and thus did not fulfill the confirmatory data requirements of the accelerated approval granted by the U.S. FDA nor the conditional marketing approvals granted in other countries, Takeda said in a statement.
Mobocertinib, sold under the brand name Exkivity, is used for the treatment of non-small cell lung cancer. The drug was approved for medical use in the United States in September 2021.
Takeda said it will continue to assess the impact of the withdrawal and update its full-year, consolidated forecast for the fiscal year ending March 31, 2024.
TAK closed Monday's regular trading at $15.28 down $0.19 or 1.23%. In the after-hours trade, the stock dropped $0.28 or 1.83%.
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