A week after Eli Lilly reported the confirmatory study for its cancer drug Lartruvo had failed to help patients live longer, the FDA is discouraging new patients from getting started on the medicine and urging those already on it to consult with their doctors.
The recommendations comes on the heels of a similar announcement from the EMA.
Lartruvo first won an accelerated approval at the FDA in 2016 as part of a combo with the chemotherapy doxorubicin. It was to be a first-line treatment for a subset of patients with soft tissue sarcoma, which had seen no new approvals in decades. By the third quarter of 2018, Lilly had raked in $221.2 million in Lartruvo sales last year.
While a small mid-stage study involving 133 patients presented encouraging data, the Phase III trial that was meant to cement the approval instead showed no difference in survival between the groups taking the Lartruvo/doxorubicin combo and doxorubicin alone. But data revealed by the EMA on Wednesday demonstrated that overall survival was 20.4 months for the combo versus 19.7 months for doxorubicin, with a dismal hazard ratio of 1.05. Chemo alone actually edged out the combo in progression-free survival: 6.8 months compared to 5.4 months.
“In light of this information, the FDA recommends that patients who are currently receiving Lartruvo should consult with their healthcare provider about whether to remain on the treatment,” an agency spokesperson told Endpoints News, adding that it was also recommending Lartruvo not be initiated in new patients outside of an investigational study.
The agency has recently finalized its guidance on labeling therapies OK’d under the accelerated approval pathway, providing more structure for a mechanism that it seems increasingly eager to use.
Lilly last Friday said it was suspending its promotion of Lartruvo, in a release announcing the drug had failed its confirmatory late-stage study.
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