The FDA Has Been Urged to Approve A Cancer Therapy

One of the hardest diseases to fight is cancer, but there’s a cutting-edge cancer therapy out there could help save many lives. It was on Wednesday this week that an advisory panel unanimously urged the Food and Drug Administration to approve CTL019. The cancer therapy fights leukemia by genetically altering the patients own immune system.

Carl June developed the therapy at the University of Pennsylvania and licensed it to Novartis to treat pediatric acute lymphoblastic leukemia. Back in 2014, US regulators designated the therapy as a “breakthrough therapy”. It was the very first cancer immunotherapy to receive this designation after 89% of the patients with leukemia saw
their cancer disappear in early trials.

The way CTL019 works is that it uses a patient’s white blood cells, or T-cells, and changes them so they can recognize and kill cancer cells. These cells are genetically programmed in the lab to target cancer cells that produce a protein called CD19. These altered white blood cells are then put back into the patient’s body where they multiply and attack the cancer.

Emily Whitehead was a six year old who underwent the experimental therapy and now at the age of 12 she is cancer free. She and her parents were at the hearing on Wednesday.

“Although this therapy is technologically somewhat complicated and is associated with certain serious side effects, it, indeed, has been proven to be amazingly effective,” said Kanti Rai, chief of the chronic lymphocytic leukemia research and treatment program at Northwell Health Cancer Institute in New York.

Side effects have included fever and crashing blood pressure.