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EMA Recommends Withdrawal of Marketing Authorisation for Olaratumab

The results of the ANNOUNCE study show that olaratumab with doxorubicin does not prolong the lives of patients with soft tissue sarcoma
29 Apr 2019
Sarcomas;  Anticancer agents & Biologic therapy

The European Medicines Agency (EMA) announced in the meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) held from 23 to 26 April 2019 that the Committee completed its assessment of the results of the ANNOUNCE study. The CHMP concluded that olaratumab (Lartruvo) with doxorubicin does not prolong the lives of patients with soft tissue sarcoma more than doxorubicin alone. Therefore, the Committee recommended that the conditional marketing authorisation of the medicine be revoked.

The review of Lartruvo was initiated in January 2019 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. 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 authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is paucity of suitable medicines. 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 authorisation. The medicine was therefore granted a conditional marketing authorisation on condition that the company provided additional data from the ANNOUNCE study. 

The phase III ANNOUNCE study of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma did not confirm the clinical benefit of Lartruvo. 

The study did not meet its primary objective to prolong survival in the overall population (stratified hazard ratio [HR]: 1.05; median 20.4 for Lartruvo plus doxorubicin versus 19.8 months for placebo plus doxorubicin) or in the leiomyosarcoma sub-population (HR: 0.95; median 21.6 months for Lartruvo plus doxorubicin versus 21.9 months for placebo plus doxorubicin). 

Additionally, no benefit was shown in terms of prolonging progression-free survival in the overall population (HR: 1.23; median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for placebo plus doxorubicin), which was one of the secondary objectives of the study. 

As a consequence, the marketing authorisation of Lartruvo will be revoked and no new patients will be able to receive Lartruvo. 

For patients already on treatment with Lartruvo, doctors should consider the available treatment options.

 

Last update: 29 Apr 2019

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