FDA approves Keytruda for ovarian cancer

Photo Source: Freepik

Keytruda belongs to a class of immunotherapy drugs known as PD-1 inhibitors. Cancer cells can evade the immune system by exploiting a protein called PD-1 on the surface of immune cells, essentially using it as a shield. The drug blocks this protein, allowing immune cells (T-lymphocytes) to once again recognize and attack the tumor.

The new indication covers patients with platinum-resistant ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma. Platinum resistance means the tumor has stopped responding to platinum-based chemotherapy (carboplatin, cisplatin), which is the backbone of standard ovarian cancer treatment. This is one of the most challenging clinical scenarios: when the disease recurs after platinum therapy, treatment options become severely limited.

The approval is based on results from the large Phase III clinical trial KEYNOTE-B96, which enrolled 643 patients with platinum-resistant ovarian cancer.

Keytruda-based regimens reduced the risk of disease progression or death by 28% compared to placebo. Median overall survival — the time point at which half of study participants were still alive — was 18.2 months in the Keytruda group versus 14 months in the control group.

Ovarian cancer is one of the most dangerous gynecological malignancies. It is often diagnosed at advanced stages because reliable early screening methods do not yet exist and early symptoms are nonspecific. Among all cancers of the female reproductive organs, ovarian cancer has the highest mortality-to-incidence ratio.

In Russia, pembrolizumab has been registered since 2016: the original Keytruda by MSD, the biosimilar Pembroria by Biocad (since 2022), and Arfleida by R-Pharm (since 2024).

Keytruda (pembrolizumab) is the world’s best-selling drug. Global sales reached $29.5 billion in 2024 and $31.7 billion in 2025. The drug has been approved by the FDA for more than 40 indications across various types of cancer.

Source: MSD