What does the Ministry of Health say about "Russian cancer medicine"?

After the Russian-made cancer drug Pembroria was recently granted circulation registration by the Drug Administration, it received the attention of many people, especially cancer patients.

Besides, there are also many opinions that this drug is in phase 3 clinical trial, not yet widely circulated and when the circulation registration certificate is granted in Vietnam, clinical trials will be conducted in Vietnam.

A representative of the Drug Administration of Vietnam said that Pembroria has completed clinical trials and has been licensed for widespread circulation in Vietnam. The issuance of a registration certificate for Pembroria means that it can be distributed and used widely like other drugs.

Russian cancer drug has not yet undergone phase 3 clinical trials? -0 — Vietnam has about 100 effective drugs and biological products for cancer treatment.

Although the drug has met the safety and quality standards for circulation, the manufacturing company will continue to monitor and evaluate the drug's immunogenicity for Vietnamese people. This is a mandatory requirement for the biosimilar group of drugs, because immunogenicity can cause an immune reaction in the user's body.

During the circulation process, enterprises are responsible for monitoring and periodically reporting on the safety, effectiveness and immunogenicity of the drug after 3 or 5 years, as required by the management agency.

Pembroria is a biosimilar, or "copy" of the drug Keytruda developed by MSD (USA). Both contain the active ingredient Pembrolizumab - a monoclonal antibody that helps the immune system recognize and attack cancer cells. Keytruda was first approved by the US in 2014 and is currently one of the most popular immunotherapies in cancer treatment in the world .

According to the representative of the Drug Administration, this is a monoclonal antibody for cancer treatment, not a new drug. Pembroria is only a similar biological product to the original reference biological product pembrolizumab of MSD Pharmaceuticals (a multinational pharmaceutical company in the US) which has been licensed for circulation since 2017. However, having more cancer treatment drugs also opens up access opportunities for patients.

According to information from the drug registration agency, Pembrolizumab has more than 14 indications for different types of cancer such as: Non-small cell lung cancer, melanoma, colorectal cancer, cervical cancer, renal cell carcinoma, breast cancer...

In addition, the drug is also indicated in the treatment of tumors with specific gene mutations such as MSI-H, high TMB or PD-L1 positive. In clinical practice, pembrolizumab is often used when the cancer has metastasized, or when the patient does not respond to traditional methods such as surgery, radiotherapy or chemotherapy.

Currently, the drug Pembroria, produced by Limited Liability Company "PK-137" (Russia), costs about 18 million VND/bottle. Patients usually use 2 bottles for 1 treatment course; lasting 12-24 courses until they no longer respond to the drug, then stop. Each month, the patient will be treated once. Meanwhile, in Vietnam, the price of Keytruda is about 55-60 million VND/bottle.

To introduce Pembroria into treatment, hospitals will have to conduct bidding and procurement. Currently, Pembroria is not covered by health insurance.

According to a representative of the Drug Administration, in addition to the above Russian drug, Vietnam currently has 99 types of cancer drugs that have been granted circulation registration and are still in effect.

Source: https://cand.com.vn/y-te/bo-y-te-noi-gi-ve-thuoc-chua-ung-thu-cua-nga--i787835/