Exkivity

2023: Worldwide batch recall

On 2 Oct 2023, the Japanese pharmaceutical company Takeda announced the withdrawal of Exkivity (mobosertinib) for the treatment of non-small cell lung cancer (NSCLC). Tests of the drug did not confirm its effectiveness.

The U.S. Food and Drug Administration (FDA) approved Exkivity in 2021 as the first oral drug for adult NSCLC patients with a specific gene mutation, an insertion in 20 exon of the EGFR gene, in whom the disease progressed during or after chemotherapy. The FDA decision was based on the results of the Phase 1 and Phase 2 studies. However, the phase 3 study did not Exclaim-2 meet expectations.

Exkivity

Trials have Exclaim-2 reportedly investigated the safety and efficacy of Exkivity as a monotherapy compared to chemotherapy. The study did not reach its primary endpoint: Takeda acknowledged that the findings did not meet the requirements that are required to pass accelerated drug approval in the United States.

The recall of Exkivity in the American market will be carried out in collaboration with the FDA. In addition, recall campaigns will be initiated in all other countries where the medicine was available.

Takeda notes that the data obtained during the development and testing of Exkivity will be used in further studies of drugs for the treatment of NSCLC. The World Health Organization estimates that non-small cell lung cancer is the most common form of lung tumor, accounting for approximately 85% of the approximately 2.2 million new cases of lung malignancies diagnosed each year worldwide.^[1]

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