FDA approves new kind of cancer treatment

The indication includes tumors that progressed following prior treatment and have no suitable alternative therapies, as well as colorectal cancer that progressed during or after treatment with chemotherapy.

"This is an important first for the cancer community", said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence.

The approval marks the first time the USA health regulator has approved a cancer drug based on a biomarker - a biological signal that suggests an increased or decreased risk for a disease.

PharmaTimes explains that MSI results in a cells inability to fix errors in its DNA sequence that occurs during a cell division, and MSI-H is a well known biomarker for certain types of cancer.

Beyond CRC, other tumor types in which patients had responses included endometrial cancer (five patients), biliary cancer (three patients), gastric or GE junction cancer (five patients), pancreatic cancer (five patients), small intestinal cancer (three patients), breast cancer (two patients), prostate cancer (one patient), esophageal cancer (one patient), retroperitoneal adenocarcinoma (one patient) and small cell lung cancer (one patient). These inhibitors work to help the immune system fight cancer by preventing tumors from evading detection. It was approved to treat advanced melanoma, advanced NSCLC, head and neck cancers, classical Hodgkin lymphoma and bladder cancer.


The FDA uses the accelerated approval pathway for patients with serious diseases that have no adequate treatment or when a drug is likely to provide clinical benefits. The approval is granted on the basis of preliminary studies and remains contingent on completion of confirmatory studies. The ORR was 36% in patients with CRC and 46% in patients with other tumor types. About 5 percent of people with spreading colorectal cancer have this biomarker. The primary endpoint was overall response rate and durability of response. Treatment with the drug led to objective responses in 40% of the patients, and the responses persisted for 6 months or longer in 78% of cases.

The most common adverse reactions were fatigue, pruritus, diarrhea, decreased appetite, rash, pyrexia, cough, dyspnea, musculoskeletal pain, constipation, and nausea. And women who are pregnant or breastfeeding shouldn't take Keytruda because it could harm a developing fetus or newborn.

By taking a genetic screening test, which is widely available for between $300 and $600, you can see if you carry the MSI-H biomarker that accompanies many forms of cancer, like those Keytruda covers.

In a groundbreaking approval, the FDA has paved the way for the country's first cancer medication that isn't targeted at only one part of the body.


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