Japanese pharmaceutical company Takeda has opted to withdraw its cancer drug Exkivity (mobocertinib) from the market following a clinical trial that failed to demonstrate its efficacy as anticipated. The drug was initially approved in 2021 for use as a second-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon20 mutations. This made it the first orally active EGFR-targeting drug for such patients who had progressed despite platinum-based chemotherapy.
However, the phase 3 EXCLAIM-2 trial results did not meet its primary endpoint, casting doubt on the drug’s effectiveness. Takeda had previously estimated that Exkivity could generate up to $600 million in peak sales if it received approval for first-line treatment of exon20-positive NSCLC.
Takeda is now collaborating with the FDA to withdraw Exkivity globally, although the drug will remain available during this process. The FDA has recently become more vigilant in enforcing the removal of drugs from the market when they fail to meet confirmatory study requirements, especially for those granted accelerated approvals.
The setback for Exkivity comes as Takeda seeks to replace the impending loss of market exclusivity for its $4 billion-a-year inflammatory bowel disease therapy, Entyvio, set for 2025, with new therapies as part of its “Wave1” initiative.
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