Russia’s cancer drug: Approved in Vietnam or still under trial?

Many are asking whether the cancer drug is approved or still in clinical trials in Vietnam.

The administration has granted registration certificates for 14 vaccines and biological products.

Among them is Pembroria containing pembrolizumab with a concentration of 100mg/4ml, produced by a Russian company and registered for use in Vietnam by a firm based in the United Arab Emirates.

Since Tuesday, some public discussions have suggested that Pembroria is only in phase-3 clinical trials in Vietnam and that the approval for circulation may be premature.

Others have described the product as a breakthrough offering hope to many patients, even referring to it as a cancer vaccine.

A representative of the administration told reporters on Wednesday that both of these views are inaccurate.

Before being licensed for circulation in Vietnam, the product dossier was reviewed by pharmacology experts from the Hanoi Medical University, who confirmed that it met the required standards for efficacy and immunogenicity, comparable to the original reference drug.

Pembroria is a monoclonal antibody that has undergone clinical trials in phases 1, 2, and 3, with the latest phase-3 study completed in January 2024.

However, when the product was registered in Vietnam, stricter requirements were imposed, including regular three-month evaluations of immunogenicity, efficacy, and risk management.

“These requirements are higher than usual," the representative said.

It is incorrect to assume that the product was approved for circulation before finishing its clinical trials.

Also, this is a therapeutic drug, not a vaccine, the representative emphasized.

Besides, this type of monoclonal antibody is not entirely new in Vietnam as the country has approved similar reference drugs since 2017.

As of Tuesday, the administration had licensed 99 monoclonal antibody drugs for cancer treatment for use, including Pembroria.

Like other drugs in its class, Pembroria is indicated for conditions such as melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial carcinoma, esophageal carcinoma, colorectal cancer, cervical cancer, triple-negative breast cancer, gastric adenocarcinoma, and biliary tract cancer.

Treatment must be prescribed and supervised by a qualified specialist, and depending on the case, Pembroria can be used in adults or adolescents aged 12 and older.

Additional information on Pembroria

Pembroria is produced by Russia’s Biocad and registered in Vietnam through a UAE-based company.

Licensing the drug allows it to be imported, distributed, and used widely like any others, as it is not classified as a special or restricted drug.

The original drug Keytruda, produced by American multinational pharmaceutical company MSD and containing the same active ingredient pembrolizumab, was first approved in Vietnam in 2017.

Both Keytruda and Pembroria contain pembrolizumab, enabling the body’s immune system to recognize and attack cancer cells.

The introduction of the new cancer drug provides Vietnamese patients with additional options for immunotherapy, particularly as demand for cancer treatment continues to rise.

Experts also expect the drug to be priced lower than the original product, although the manufacturer of the reference drug has its own pricing reduction plans.

In Russia, Pembroria was approved in April 2022.