Use of Pembrolizumab Expanded to 13th Type of Cancer in Five Years

The use of immunotherapy in the treatment of cancer has dramatically increased in the five years since the U.S. Food and Drug Administration (FDA) first approved the groundbreaking immunotherapeutic pembrolizumab (Keytruda). Since that September 2014 approval, for melanoma, pembrolizumab has been approved for use in the treatment of another 12 types of cancer, most recently endometrial cancer, and the treatment of any type of solid tumor that tests positive for either of two specific biomarkers, microsatellite instability–high or mismatch repair–deficient.

Read More

AACR Annual Meeting 2019: PD-1 Pandemonium

“Do you want to have fun?” Richard Pazdur, MD, director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, asked the audience as he opened the “PD-1 Pandemonium: FDA Speaks with Industry on the Past, Present, and Future of PD-1 Drugs” regulatory science and policy session at the American Association for Cancer Research (AACR) Annual Meeting 2019 on Monday, April 1.

Pazdur explained that he and AACR staff in the Science Policy and Government Affairs Office thought that it would be informative to convene representatives from all the companies who have an FDA-approved PD-1– or PD-L1–targeted immunotherapeutic for a heart-to-heart conversation about the past, present, and future of this group of revolutionary cancer treatments.

Read More