Vietnam Grants Approval to Russian‑Made Immunotherapy Drug “Pembroria”

Vietnam’s Ministry of Health has recently approved a Russian‑made cancer immunotherapy drug called Pembroria for use in the country, representing a significant step toward making advanced cancer treatment more accessible. According to the country’s drug regulator, Pembroria is one of 14 vaccines and biological products granted market authorization in the latest approval round. 

What is Pembroria?

Pembroria is a biologic medicine whose active ingredient is pembrolizumab — the same immunotherapy agent used in the globally established cancer drug Keytruda. Administered as an intravenous infusion, the drug comes in 100 mg/4 ml vials and has a shelf‑life of 24 months from manufacture. 

Though Pembroria shares its mechanism and key ingredient with Keytruda — a monoclonal antibody targeting PD-1 to help the body’s immune system attack cancer cells — authorities emphasize that it is a “biosimilar,” not a brand‑new drug. The approval broadens the supply of immunotherapy options in Vietnam, which already has a range of monoclonal antibody–based treatments. 

Range of Use — What Cancers It Targets

The regulatory license for Pembroria includes a wide spectrum of cancer types. According to information from the regulator and hospitals, approved indications cover many solid tumors and some other cancer forms:

• Non–small cell lung carcinoma 

• Melanoma (skin cancer) 

• Head and neck squamous cell carcinoma 

• Classical Hodgkin lymphoma 

• Urothelial carcinoma (bladder/urinary tract) 

• Esophageal carcinoma

• Colorectal cancer (especially with high microsatellite instability or mismatch repair defects) Cervical cancer 

• Renal (kidney) cell carcinoma 

• Endometrial (uterine) carcinoma 

• Triple‑negative breast cancer

• Gastric (stomach) or gastroesophageal‑junction adenocarcinoma 

• Biliary tract (cholangiocarcinoma) cancer 

This wide range reflects Pembroria’s use as a general immunotherapy agent when cancer has progressed or conventional treatments (surgery, chemotherapy, radiotherapy) are not effective. 

What This Could Mean for Vietnamese Patients

The approval of Pembroria is expected to broaden access to advanced immunotherapy in Vietnam, potentially offering a more affordable alternative to existing options. According to statements from K Hospital in Hanoi — which plans to begin offering Pembroria — each vial may cost around VND 18 million, with typical treatment cycles using two vials (i.e., VND 36 million per cycle). This is substantially less expensive than Keytruda, whose listed price is much higher. 

Health experts and regulatory officials also note that the introduction of a biosimilar such as Pembroria helps diversify treatment supply, which may drive down costs and reduce reliance on a small number of imported branded drugs. 

However, not all patients will be eligible for Pembroria. Whether a patient can receive the drug depends on a range of factors including cancer type, tumor characteristics, disease stage, and overall health — decisions to use it must be made on a case‑by‑case basis by oncologists. 

In addition, while Pembroria has been authorized for circulation, it is not yet covered by Vietnam’s public health insurance system. 

Context: Why This Matters

Cancer remains a growing public health challenge in Vietnam. According to national data, the number of cancer cases and deaths has been rising in recent years — underscoring the urgency of expanding treatment options beyond conventional therapies. 

By granting circulation approval to a biosimilar immunotherapy, regulators are effectively increasing the accessibility of advanced treatments, which may help alleviate some of the burden posed by high‑cost branded drugs. As noted by oncology experts, this move aligns with broader efforts to improve equity in cancer care. 

At the same time, medical professionals stress the need for careful, individualized treatment planning — immunotherapy is not a “one‑size‑fits-all” solution, and effectiveness can vary widely depending on patient-specific factors.