The first Immuno-Oncology Drug of the Innovative PD-1 Inhibitor Class has been Approved in Russia

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MSD, known as Merck & Co. in the United States and Canada, informs that the first-in-class of the PD-1 inhibitors immuno-oncology drug, pembrolizumab, has been approved in Russia. This drug is indicated for the treatment of adult patients with unresectable or metastatic melanoma, as well as for the treatment of patients with advanced non-small-cell lung cancer with confirmed PD-L1 expression by tumor cells and disease progression during or after platinum-based therapy. The Registration Certificate for the drug, No. LP-003972 (ЛП-003972), was issued by the Ministry of Health of the Russian Federation and is available on the website of the State Registry of Medicinal Products.

The Registration Dossier for the medicinal product contains results from four clinical studies with over 2 000 patients enrolled, including subjects in the Russian Federation.

Pembrolizumab reactivates the immune system’s ability to attack the tumor. The immune system does not always recognize cancer cells as foreign cells, thus allowing some types of malignancies to avoid timely detection and destruction. Pembrolizumab deprives tumor cells of the ability to escape immunological control and returns the capacity to destroy tumor to the immune system’s components.

Sergey Tyulyandin, Deputy Director, Federal State Budget-funded Establishment N.N. Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation; Chairperson, Society of Clinical Oncology:

“The approval in Russia of the first immuno-oncology agent of the class of PD-1/PD-L1 checkpoint inhibitors is an essential addition to our anticancer armamentarium. Pembrolizumab, like the other agents with similar mechanism of action observed during clinical trials, is intended to activate the patient’s own protective system. Activation of antitumor immunity by means of checkpoint inhibitors results in improvement of the overall survival and quality of life of patients with malignancies. Pembrolizumab, in particular, has been shown to be more effective than standard treatment in patients with non-small-cell lung cancer who had previously received chemotherapy, and was approved for their treatment in Russia. The importance of the PD-L1 biomarker has to be mentioned; determination of this biomarker will allow to identify patients likely to benefit most from pembrolizumab therapy.”

Lev Demidov, Head, Department of Biological Therapy, Federal State Budget-funded Establishment N.N. Blokhin Russian Cancer Research Center of the Ministry of Health of the Russian Federation; Chairperson, Association of Melanoma Experts “Melanoma.Pro”:

“Immuno-oncology today is one of the most promising areas in the treatment of tumors, including skin melanoma. The approval of pembrolizumab in our country will surely give a new chance to patients with skin melanoma by helping achieve better control of metastatic disease.”

Sergey Babkin, BU Director Oncology, MSD Russia:

“Pembrolizumab is a telling example of how scientific achievements can help people with the most complicated diseases. The approval of this drug in Russia is a great step towards providing physicians with an innovative tool for the treatment of patients with advanced melanoma and lung cancer, conditions that were previously extremely unresponsive to treatment. Our top priority at present is a continuation of the interaction with the Federal authorities to make the drug available to patients that can benefit from this treatment, as soon as possible”

Pembrolizumab received the first marketing authorization in 2014 in the United States as a treatment for patients with unresectable and metastatic melanomas with disease progression after previous therapy. It was later approved for use in treatment-naive patients with unresectable and metastatic melanomas and for the treatment of patients with metastatic lung cancer with PD-L1 overexpression, as well as for relapsing metastatic tumors of the head and neck region. At present, FDA is reviewing marketing authorization applications for a drug proposed for the treatment of advanced colorectal cancer and bladder cancer, as well as Hodgkin’s lymphoma.

As of November 2016, pembrolizumab was approved in over 50 countries, including the United States, Israel, European Union member states, Canada, Turkey, and India.

It is expected that pembrolizumab will become available in Russia in the second quarter of 2017. The drug will be manufactured at the MSD’s manufacturing site in Ireland. The final stage of the manufacture, including secondary packaging and quality control release testing, will be performed at the Ortat CJSC plant located in Kostromskaya region, part of the R-Pharm group of companies.

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