Keytruda Immunotherapy FDA Approval – Cancer Treatment for Tumors with Specific Genetic Markers

In May 2017 the FDA granted accelerated approval to an immunotherapy cancer treatment for patients whose cancers have a specific genetic feature (biomarker). This approval marked the first time the FDA approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.

Keytruda is a cancer immunotherapy drug, which works with a cancer patients immune system to help fight cancer. It is not a chemotherapy or radiation therapy. This cancer fighting immunotherapy works on specific types of cancers, including melanoma (skin cancer), a type of lung cancer called non–small cell lung cancer (NSCLC), classical Hodgkins lymphoma, head and neck squamous cell cancer, advanced urothelial bladder cancer, and  microsatellite instability-high (MSI‑H) cancers. The latest FDA approval is on Keytruda is specifically for the MSI-H or dMMR genetic marker. Read more

FDA announces approval, CMS proposes coverage of first breakthrough-designated test to detect extensive number of cancer biomarkers

FDA Announces Approval of FoundationOne CDx, Foundation Medicine’s Cancer Gene Diagnostic Test for Solid Tumors FDA approves test to detect mutations in 324 genes, two genomic signatures. Second to be approved with proposed coverage under FDA/CMS Parallel Review Program. Agencies’ parallel review process makes test for efficient identification of multiple targeted therapy options available to […]