Urgently provide widely available clinical research information on Pembroria drug

(Dan Tri) - The Drug Administration of Vietnam, Ministry of Health is urgently reviewing records of clinical research stages of the Russian-made Pembroria cancer treatment drug, to widely provide it to the community.

The above information was shared by the leader of the Drug Administration of Vietnam, Ministry of Health with Dan Tri reporter at noon on November 14.

Specifically, in the past few days, information about the anti-cancer drug Pembroria (with the main active ingredient Pembrolizumab) produced by a unit in Russia after being posted has attracted special attention from public opinion.

In addition to opinions expressing hope that cancer patients will have the opportunity to access immunotherapy in treatment at a more suitable price, many people also expressed concern when the Drug Administration required the above drug manufacturing and registration facilities to periodically update the progress of clinical research implementation and monitor phase 3 immunogenicity every 3 months.

In addition, some medical experts expressed concern that patients would doubt that drugs without clinical evidence of efficacy had been put into use. Or they might also ask, are they the beneficiaries, or are they just using the drug as participants in the research process?

The anti-cancer drug Pembroria has the main active ingredient Pembrolizumab (Photo: incentra).

Responding to the above issues, the leader of the Drug Administration of Vietnam, Ministry of Health affirmed that Pembroria has conducted phase 3 clinical research comparing with reference drugs on more than 600 patients, and this research phase will be completed in 2024.

Pembroria medicine was also licensed in Russia, Cuba, UAE (United Arab Emirates) before being granted registration for circulation in Vietnam.

Regarding the contents stated in Decision No. 628/QD-QLD issued on October 31, the Drug Administration of Vietnam said that it has implemented the regulations stated in Circular 12/2025/TT-BYT of the Ministry of Health on registration of circulation of drugs, pharmaceutical ingredients, as well as guidelines for development of biosimilar drugs of the World Health Organization (WHO).

Faced with mixed public opinions, the leader of the Drug Administration Department said that he had directed the Drug Registration Department to review records and coordinate with the professional council to urgently prepare accurate information to widely provide to the community, related to the results of clinical research at all stages of the drug Pembroria.

According to Decision No. 628/QD-QLD dated October 31 issued by the Department of Drug Administration, Ministry of Health, there are 14 vaccines and biological products that have been granted a circulation registration certificate in Vietnam with a validity of 3 years - batch 57.

Among them, there is the drug Pembroria (main active ingredient is Pembrolizumab, content 100mg/4ml) produced by Limited Liability Company "PK-137" (Russia), registered by a facility in the United Arab Emirates.

Pembroria medicine is prepared in the form of a concentrated solution for infusion, with a shelf life of 24 months from the date of manufacture.

Notably, according to information from the drug registration agency, Pembroria has more than 14 indications for different types of cancer.

The Drug Administration of Vietnam affirms that a drug that is granted a circulation registration certificate means it is allowed to circulate on the market, so it cannot only be used for research and clinical trials.

During the circulation process, Pemboria drug must fully comply with regulations and periodically update the results of phase 3 immunogenicity clinical trials (stipulated in points a and c, clause 1, Article 24 and point b, clause 2, Section 2, Appendix I, Circular 12/2025/TT-BYT for similar biological products).

According to information from the Drug Administration, Pembroria is a monoclonal antibody, produced based on the original reference biological product of the pharmaceutical company MSD (USA). Previously, Keytruda - another drug with the main active ingredient Pembrolizumab - was licensed for circulation in Vietnam.

Source: https://dantri.com.vn/suc-khoe/khan-truong-cung-cap-rong-rai-thong-tin-nghien-cuu-lam-sang-thuoc-pembroria-20251114131612186.htm