Other safety alerts
|
| |
| Canada: Lartruvo (olaratumab) - New clinical trial information important to prescribing decisions |
| |
Health Canada announces that the ANNOUNCE trial, a global, randomized, placebo-controlled Phase III study of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the clinical benefit of Lartruvo in combination with doxorubicin as compared to doxorubicin alone, a standard of care treatment.
In Canada, Lartruvo has been issued marketing authorization with conditions based on the promising evidence of an overall survival benefit demonstrated in a Phase II study. Continued authorization was contingent on verification of clinical benefit in a confirmatory Phase III study. In Canada, as of 28 Jan 2019, there are approximately 180 patients undergoing treatment with Lartruvo.
The ANNOUNCE trial, a global, randomized, placebo-controlled Phase III study of Lartruvo in combination with doxorubicin in patients with advanced or metastatic STS, did not confirm the clinical benefit of Lartruvo in combination with doxorubicin as compared to doxorubicin, a standard of care treatment. Specifically, the study did not meet the primary endpoints to prolong survival in the overall population (hazard ratio [HR]: 1.05; Median 20.4 vs. 19.7 months for Lartruvo + doxorubicin and doxorubicin, respectively) or in the leiomyosarcoma (LMS) sub-population (HR: 0.95; Median 21.6 vs. 21.9 months for Lartruvo + doxorubicin and doxorubicin, respectively). There was also a shortening in progression free survival in the Lartruvo plus doxorubicin arm (median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for doxorubicin), which was one of the secondary objectives of the study. Based on the information available so far, no new safety concerns were identified during the study.
Information for health care professionals:
- Patients who currently are receiving Lartruvo should discuss with their physician whether to continue their course of therapy.
- No new patients should start Lartruvo treatment outside of an investigational setting.
- Effective immediately, enrollment in the LillyPlus™ Patient Support Program (PSP) is closed for patients who have not yet initiated therapy with Lartruvo. Patients already enrolled in the LillyPlus™ PSP and receiving treatment with Lartruvo will continue to receive the same services currently provided, should they decide to remain on therapy.
Health Canada is currently working with the manufacturer to determine the appropriate next steps. Lilly is in the process of reviewing the full results of the ANNOUNCE study and is working with global regulators to determine the appropriate next steps for Lartruvo.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../68974a-eng.php
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., 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 (EMA), and was posted on the Drug Office website on 24 Jan 2019. Letters to inform local healthcare professionals were issued by the DH on the same day. As further assessment of the study results is ongoing, the DH will remain vigilant on safety update of the drug issued by EMA and Health Canada, and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Jan 31, 2019
Issued at HKT 15:00
|
| |
|
