Exkivity Withdrawal Is Blow To Takeda’s Oncology Ambitions
The withdrawal of the targeted anticancer comes as no surprise after its Phase III missed in July, but it sets back Takeda’s expansion plans in the competitive therapy area.
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While the weaker yen boosted the top line for Japanese pharma companies with a strong global presence in the fiscal first half, it also raised reported costs. Several firms reported strong growth for mainstays, while holding out high hopes for selected new drugs with blockbuster potential. But some other products underperformed for unexpected reasons.
The US FDA approved Fruzaqla (fruquintinib) for previously treated metastatic disease regardless of biomarker status. The drug, already approved in China, was de-risked when Takeda licensed it from HutchMed.
Accelerated Approvals: Conversions Still Outweigh Withdrawals, But Takeda’s Exkivity Brings 2023’s Pull Count To Six
US FDA’s Oncologic Drugs Advisory Committee will convene in November for a ‘general discussion about delayed confirmatory trials’ and the ‘continued optimization of the accelerated approval process.’