Tag: KEYTRUDA

Promega Intends to Seek FDA Approval for Microsatellite Instability Assay to Assist in Strategic Cancer Decisions

| July 9, 2017 | 0 Comments

Promega Corporation intends to seek FDA approval and CE-IVD marking for a commercially available Microsatellite Instability (MSI) assay to assist oncologists and pathologists in determining colorectal cancer decisions. The current Promega Research Use Only MSI Assay has been available and used in the market as part of Lab-Developed Tests since 2004 and is considered the […]

Continue Reading

FDA Approval of Immunotherapy For MSI-High or Mismatch Repair Deficient Tumors

| June 5, 2017 | 0 Comments

Last month the FDA approved pembrolizumab (KEYTRUDA) for adult and pediatric patients with with metastatic or unresectable, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment. KEYTRUDA has also been approved fro MSI-H or dMMR colorectal cancers that have progressed following treatment with conventional chemotherapies. The immunooncology/immunotherapy story is fascinating. […]

Continue Reading