Other safety alerts
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| European Union: EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo |
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European Medicines Agency (EMA) has completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. EMA is therefore recommending that the marketing authorisation of the medicine be revoked.
In January 2019, when preliminary results of the ANNOUNCE study became available, EMA recommended that no new patients should start treatment with the medicine. Having now assessed the full data from the study, EMA 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 by EMA 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 EMA’s recommendation will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
Information for patients:
- Lartruvo was approved to treat a rare type of cancer called soft tissue sarcoma. It was approved on condition that the company carried out a study to confirm its benefits.
- However, that study showed that Lartruvo with doxorubicin is no better than doxorubicin alone at prolonging patients’ lives.
- The marketing authorisation of Lartruvo will therefore be withdrawn and no new patients will be treated with the medicine.
- If you are already being treated with Lartruvo, your doctor will consider the most appropriate treatment for you.
- There are no new safety concerns with the medicine.
Information for healthcare professionals:
- The phase 3 study ANNOUNCE 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.
- No new safety concerns were identified during the study.
Please refer to the following website in EMA for details:http://www.ema.europa.eu/en/news/ema-recommends-withdrawal-marketing-authorisation-cancer-medicine-lartruvo
In Hong Kong, there are 2 registered pharmaceutical products containing olaratumab, namely Lartruvo Concentrate For Solution For Infusion 500mg/50ml (HK-66024) and Lartruvo Concentrate For Solution For Infusion 190mg/19ml (HK-66025). Both products are registered by Eli Lilly Asia, Inc. (Eli Lilly), and are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to olaratumab. Related news was previously issued by Health Canada and European Medicines Agency (EMA), and was posted on the Drug Office website on 24 Jan 2019 and 31 Jan 2019 respectively. Letters to inform local healthcare professionals were issued by the DH on 24 Jan 2019.
In light of the above EMA’s recommendation, the DH will follow up with Eli Lilly, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Saturday, April 27, 2019
Issued at HKT 12:00
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