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DEPARTMENT OF HEALTH DRUG OFFICE

DRUG REGISTRATION AND IMPORT/EXPORT CONTROL DIVISION

3/F., Public Health Laboratory Centre, 382 Nam Cheong Street, Kowloon, Hong Kong

f,nJrc1FM Enquirie s (852) 2319 8458

WJ~~~~fil.lj Fa xline No. (852)2803 4962

DH DO PRIE/7-30/15 24Jan2019

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DH III OBA

Dear Healthcare Professionals,

No new patients should start treatment with Lartruvo after study shows cancer medicine does not prolong life in the European Union

Your attention 1s drawn to the European Medicines Agency's (EMA) announcement 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.

Health care 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.

We build a healthy Hong Kong and aspire to be an internationally renowned public health authority

-2-

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:

https://www.ema.europa.eu/en/news/no-new-patients-should-start-treatment-lartruvo-after-stud

y-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. 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. Healthcare

professionals are advised to balance the risk of possible adverse effects against the benefit of

treatment.

Please report any adverse events caused by drugs to the Pharmacovigilance Unit ofthe DH (tel.

no.: 2319 2920, fax: 2319 6319 or email: adr@dh.gov.hk). For details, please refer to the website at

Drug Office under "ADR Reporting": http://www.drugoffice.gov.hk/adr.html. You may wish to visit

the Drug Office's website for subscription and browsing of "Drug News" which is a monthly digest

of drug safety news and information issued by Drug Office.

Yours faithfully,

(~E) for Assistant Director (Drug)

We build a lzealtlzy Hong Kong and aspire to he an internationally renowned public lzealtlz authority