Other safety alerts
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| The United Kingdom: Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of efficacy |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that the ANNOUNCE study failed to show clinical efficacy for olaratumab in its current indication of advanced soft tissue sarcoma and the benefit risk balance is therefore now considered negative. No new patients should be started on olaratumab therapy.
The ANNOUNCE study did not show clinical benefit of olaratumab in combination with doxorubicin compared with doxorubicin, a standard of care treatment for advanced soft tissue sarcoma. Specifically, the study of 509 patients (258 in the investigational arm and 251 in the control arm) did not meet the primary endpoint to prolong overall survival in the study (hazard ratio 1.05; 95% CI 0.84–1.30; median overall survival 20.4 months for the olaratumab plus doxorubicin group versus 19.8 months for the doxorubicin group). Overall survival was also not prolonged by olaratumab in the subpopulation of 234 patients with leiomyosarcoma (119 in the investigational arm and 115 in the control arm; hazard ratio 0.95, 95% CI 0.690–1.312; median overall survival 21.6 months for the olaratumab plus doxorubicin group versus 21.9 months for the doxorubicin group). There was no clinical benefit for key secondary efficacy endpoints, including median progression-free survival in the overall population (hazard ratio 1.23, 95% CI 1.009–1.502; median progression-free survival 5.4 months for the olaratumab plus doxorubicin group versus 6.8 months for the doxorubicin group).
No new safety concerns were identified in the study.
Because this study did not show a clinical benefit, the conditional marketing authorisation for olaratumab will be withdrawn.
Healthcare professionals are advised:
- The ANNOUNCE phase 3 study (an EU regulatory requirement) to assess olaratumab (Lartruvo▼) in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma failed to show a clinical benefit.
- The benefit-risk balance of olaratumab is therefore negative and the marketing authorisation in the EU will be withdrawn.
- Do not start new patients on olaratumab.
- For patients currently on treatment, consider alternative treatment options since available stock will expire by April 2020.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/lartruvo-olaratumab-withdrawal-of-the-eu-marketing-authorisation-due-to-lack-of-efficacy
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 European Medicines Agency and Health Canada, and was posted on the Drug Office website on 24 Jan 2019, 31 Jan 2019 and 27 Apr 2019. Letters to inform local healthcare professionals were issued by the DH on 24 Jan 2019. The DH will continue to follow up with Eli Lilly, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Thursday, Jun 20, 2019
Issued at HKT 17:00
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