When Lilly’s approved soft tissue sarcoma drug Lartruvo unexpectedly failed to help patients live longer in a late-stage study in January, US and EU regulators discouraged new patients from starting treatment with the medicine, and the drugmaker suspended its promotion of the therapy.
Lartruvo was cleared for use by the FDA under the accelerated approval pathway — an increasingly popular mechanism used by the agency to hasten the pace of approvals — in 2016, and the confirmatory Phase III trial was intended to confirm the drug’s benefit. Since the trial was unsuccessful, Lilly was expected to rescind the drug from the market. On Thursday, the company $LLY said it was working on setting up a program so current patients can still access Lartruvo with “limited interruption” after it is officially withdrawn.
Lilly said it was unable to speculate when the drug will be officially withdrawn, a spokesperson told Endpoints News.
Lartruvo, which generated nearly $305 million in sales last year, was approved in combination with the chemotherapy doxorubicin as a frontline treatment for a subset of patients with soft tissue sarcoma (STS), a disease that had seen no new approvals in decades.
In 2019, an estimated 12,750 new STS cases will be diagnosed, and more than 5,000 Americans will succumb to the disease, according to the American Cancer Society.
“(P)atients who are currently receiving Lartruvo may, in consultation with their physician, continue their course of therapy if they have been informed of the risks of Lartruvo and the results of the (failed) ANNOUNCE study and wish to continue, subject to local laws and regulations,” Lilly said in a statement.
Physicians will need to work with the company to set up contracts to enroll their facilities, and patients will need to provide written consent to enroll in the program — if these steps are taken then current patients should be able to access Lartruvo free of charge, the spokesperson said.
The US list price for the drug was $2,456 per 500 mg vial and $933.28 per 190 mg vial, and the average price at six month duration of exposure would be $106,099.20, the spokesperson noted, adding that a patient’s out-of-pocket cost would depend on various factors including insurance coverage and medical assistance programs.
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