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Regulatory Focus™ > News Articles > 2019 > 4 > EMA Calls for Cancer Drug Withdrawal Following Negative Trial Results

EMA Calls for Cancer Drug Withdrawal Following Negative Trial Results

Posted 26 April 2019 | By Zachary Brennan 

EMA Calls for Cancer Drug Withdrawal Following Negative Trial Results

Just a day before the European Medicines Agency (EMA) announced its recommendation Friday that the marketing authorization of Lilly’s Lartruvo (olaratumab) should be revoked, Lilly said it’s working on plans to pull the medicine from the market.

The EMA announcement, which followed an earlier announcement expressing caution in January, confirmed that Lartruvo with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. 

The US Food and Drug Administration (FDA) also issued an announcement in January that the recently completed Phase 3 study did not confirm the clinical benefit of Lartruvo. “Specifically, the study did not meet the primary endpoint of improvement in overall survival for Lartruvo and doxorubicin as compared to placebo and doxorubicin,” FDA said.

Online commentary related to this example of an accelerated approval not living up to the early results focused on the need for proper postmarket surveillance.

Joseph Ross, associate professor at Yale School of Medicine, tweeted: “If we are tilting towards less evidence to secure approval, we need stronger and more robust requirements to generate evidence after market approval.”

He also pointed to a study from last June in JAMA Oncology explaining how for many accelerated approvals, postmarket requirements are not fulfilled.

Of the 93 accelerated approvals in malignant hematology and oncology between 1992 and May 2017, the study said: 51 (55%) have fulfilled their postmarketing requirement and verified benefit in a median of 3.4 years after their initial approval. Thirty-seven (40%) indications have not yet completed confirmatory trial(s) or verified benefit, and just five indications receiving accelerated approval (5%) have been withdrawn from the market.

Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy and Outcomes, tweeted: “If drug companies are serious about refunds for unachieved outcomes then doesn’t @LilyPad owe the money back to the various payers? Accelerated approval has become a free option with no downsides.”

Lilly sold $203 million worth of Lartruvo in 2017 and almost $305 million in 2018. Lilly said Thursday it is establishing a program to ensure current patients “will have access to Lartruvo with limited interruption after it is withdrawn from the market. The program will be established as allowed by local country regulations.”


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