EMA tells Lilly to withdraw cancer drug that was awarded accelerated approval

By PharmaCompass

2019-05-02

Impressions: 132 Article

Eli Lilly announced it has withdrawn Lartruvo (olaratumab) from the market for the treatment of advanced soft tissue sarcoma (STS). The company is establishing an Access Program for patients currently receiving the drug who may wish to continue.

Lilly’s announcement came after EMA brought out results of its ANNOUNCE study last week. EMA concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. “The Agency is therefore recommending that the marketing authorization of the medicine be revoked,” an EMA statement said.

In January 2019, when preliminary results of the ANNOUNCE study became available, the Agency recommended that no new patients should start treatment with the medicine. Having now assessed the full data from the study, the Agency has concluded that the benefit of Lartruvo in combination with doxorubicin is not confirmed. Regarding safety, the data did not show any new safety concerns.

Lartruvo was authorized in November 2016 to treat advanced soft tissue sarcoma, a rare and difficult-to-treat cancer. At the time of its approval, data on the effects of Lartruvo were limited because of the small number of patients included in the main study which supported its authorization. Therefore, Lartruvo was approved on the condition that the company carried out a study to confirm its benefits.

There is more bad news from Lilly. This week, the American drugmaker also dumped two mid-stage oncology drugs from its pipeline operations — CHK1 drug prexasertib (LY2606368) and its Phase II PI3k/mTOR inhibitor, LY3023414. Lilly plans to concentrate its oncology R&D on seven key programs that had better prospects.

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