After a confirmatory trial flop this past summer, Takeda is calling it quits on its targeted non-small cell lung cancer (NSCLC) drug Exkivity.
Takeda on Tuesday said it will work with the FDA to chart a voluntary withdrawal of Exkivity in the U.S., where the drug is approved for certain adult NSCLC patients whose disease has progressed on or after platinum-based chemotherapy. Takeda is plotting voluntary withdrawals of Exkivity around the world, too, and says it’s working with regulators in other countries on next steps.
Back in 2021, Exkivity snagged an accelerated nod as a second-line NSCLC treatment. As a condition of Exkivity’s accelerated approval, the FDA required progression-free survival data from a randomized trial to verify the drug’s clinical benefit.
In late July, however, Exkivity missed the mark in the phase 3 trial EXCLAIM-2, which Takeda stopped early. The study tested Exkivity versus platinum-based chemotherapy for NSCLC patients with EFGR exon20 insertion mutations.
Takeda says it will present full data from the trial at an upcoming medical meeting or in a peer-reviewed journal.
Even as Takeda plans to withdraw its med, the company says it’s committed to ensuring patients receiving the drug can maintain access “as appropriate and in consultation” with their doctors.
In light of the withdrawal, Takeda says it will assess and likely update its revenue forecast for fiscal year 2023, which ends on March 31, 2024.
Exkivity’s recent confirmatory trial flop came just a few days after Johnson & Johnson’s rival drug Rybrevant succeeded at delaying cancer progression in first-line NSCLC patients. Both drugs used tumor shrinkage data from single-arm trials to win accelerated nods from the FDA in 2021.
The FDA’s oncology department has lately taken a hard line on accelerated approval regulations.
In the past, the regulator has kept certain accelerated approvals intact despite confirmatory trial flops because of unmet needs. But given J&J’s phase 3 win and Rybrevant’s availability in the same disease area, that argument is largely moot in this case.
Exkivity was one of two growth drivers and launch products in Takeda’s oncology portfolio, alongside ALK lung cancer med Alunbrig. The company had projected $300 million to $600 million in peak sales for Exkivity. In the 12 months ended in March, the EGFR inhibitor pulled in 3.7 billion Japanese yen ($26 million) in sales.