Failure to Meet Primary Endpoint in Phase 3 EXCLAIM-2 Trial Leads to Voluntary Withdrawal of NSCLC Drug
In a significant development, Takeda has announced the voluntary withdrawal of its drug Exkivity (mobocertinib) from the US market. The decision comes after the drug failed to demonstrate clinical benefit in a confirmatory phase 3 trial, a requirement for its full approval.
HCN Medical Memo
The withdrawal of Exkivity serves as a reminder of the rigorous standards that therapies must meet for full approval. Although the drug showed promise in earlier trials, its inability to meet the primary endpoint in the confirmatory phase underscores the importance of robust clinical evidence. This development may necessitate adjustments in treatment plans for NSCLC patients with specific EGFR mutations.
- Exkivity received accelerated approval in 2021 for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
- The drug’s full approval was contingent on the phase 3 EXCLAIM-2 trial, which it failed to pass.
- Awny Farajallah, MD, head of Global Medical Affairs Oncology at Takeda, expressed hope that the trial’s findings would inform future research.
Approximately 85% of all lung cancers are non-small cell lung cancers.
- Exkivity remains available while Takeda works on the withdrawal timing.
- Healthcare providers can contact Takeda for treatment availability questions.
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