Emily Whitehead Foundation co-founder Tom Whitehead has been accepted as a speaker for the Oncologic Drugs Advisory Committee (ODAC) meeting on July 12, 2017. At this hearing, the U.S. Food & Drug Association (FDA) will discuss the pending approval of the Novartis manufactured CAR-T cell therapy CTL019 for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL).
In April 2012, Emily Whitehead was the first pediatric patient in the world to receive this breakthrough immunotherapy treatment, developed and administered at Children’s Hospital of Philadelphia (CHOP). The then highly experimental Phase I clinical trial was successful and, as of May 10, 2017, Emily is 5 years cancer free. [Read Emily’s story]
In the five years following, more than 150 children have been treated at CHOP and the CTL019 trial has expanded within the United States and around the world, with the associated Phase II ELIANA study helping kids in the U.S., Canada, Europe, Australia and Asia. [Read the stories of CAR-T cell patients]
On March 29, 2017, the Biologics License Application (BLA) that Novartis filed with the FDA was granted priority review status, thus expediting the approval process.
The next step toward approval is the ODAC hearing, to take place on July 12, 2017 at the FDA White Oak Campus in Silver Spring, Maryland. Emily Whitehead Foundation co-founders Tom, Kari and Emily Whitehead will be in attendance, and Tom Whitehead will speak before a panel of experts during the time allotted for public comments.
With FDA approval, the CTL019 CAR-T cell therapy would no longer be constrained to clinical trials—effectively making this life-saving cancer immunotherapy treatment accessible to many more children around the world! [Learn more about CAR-T cell therapy]