其 他 安 全 警 示
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| European Union: No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life (English Only) |
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European Medicines Agency (EMA) announces that preliminary results from the ANNOUNCE study show that Lartruvo (olaratumab) in combination with doxorubicin is not more effective at prolonging the lives of patients with soft tissue cancer than doxorubicin alone.
While full results from the study are awaited, EMA is recommending that no new patients should start treatment with the medicine. For patients currently being treated with Lartruvo, their doctor may consider continuing treatment with the medicine if they appear to benefit from it. It is estimated that around 1,000 patients are currently treated with Lartruvo in the European Union. Based on the information available so far, there are no new safety concerns with the medicine, with side effects reported with the combination being similar to those with doxorubicin alone.
At 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 authorisation. The medicine was therefore granted a marketing authorisation on condition that the company provides additional data from the ANNOUNCE study in order to confirm the efficacy and safety of the medicine.
Healthcare professionals will be informed in writing of the preliminary results of the study and the current treatment recommendations. EMA will communicate further as appropriate.
Information for healthcare professionals:
- The phase 3 study ANNOUNCE evaluated Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma and did not confirm the clinical benefit of Lartruvo in combination with doxorubicin as compared with doxorubicin alone.
- The study did not meet its primary objective to prolong survival in the overall population (HR: 1.05; median 20.4 vs. 19.7 months for Lartruvo plus doxorubicin and doxorubicin, respectively) or in the leiomyosarcoma sub-population (HR: 0.95; median 21.6 months for Lartruvo plus doxorubicin versus 21.9 months for 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 doxorubicin), which was one of the secondary objectives of the study.
- As a consequence, no new patients should be prescribed Lartruvo.
- While further assessment of the study results is ongoing, doctors may consider continuing Lartruvo treatment in patients who experience clinical benefit.
- No new safety concerns were identified during the study and the safety profile was comparable in the two treatment arms.
- A letter will be sent to all healthcare professionals expected to prescribe the medicine to inform them of the preliminary results of the study and the current treatment recommendations.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/no-new-patients-should-start-treatment-lartruvo-after-study-shows-cancer-medicine-does-not-prolong
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. In light of the above EMA’s announcement, letters to inform local healthcare professionals will be issued. As further assessment of the study results is ongoing, the DH will remain vigilant on safety update of the drug issued by EMA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Thursday, Jan 24, 2019
Issued at HKT 16:00
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