Takeda plans withdrawal of lung cancer therapy Exkivity from U.S. market

Takeda will work with the FDA toward voluntary withdrawal of its lung cancer therapy mobocertinib from the U.S. market, according to a company press release.
Takeda — which intends to initiate similar voluntary withdrawals in other parts of the world where the therapy is approved — made the decision after a required phase 3 confirmatory trial failed to meet its primary endpoint.
The FDA granted accelerated approval in September 2021 to mobocertinib (Exkivity, Takeda) — an oral tyrosine kinase inhibitor designed to target EGFR exon 20 insertion mutations — for treatment

Takeda will work with the FDA toward voluntary withdrawal of its lung cancer therapy mobocertinib from the U.S. market, according to a company press release.
Takeda — which intends to initiate similar voluntary withdrawals in other parts of the world where the therapy is approved — made the decision after a required phase 3 confirmatory trial failed to meet its primary endpoint.
The FDA granted accelerated approval in September 2021 to mobocertinib (Exkivity, Takeda) — an oral tyrosine kinase inhibitor designed to target EGFR exon 20 insertion mutations — for treatment