The Alliance for Regenerative Medicine Issues Statement on U.S. FDA Oncologic Drugs Advisory Committee Meeting Regarding Novartis’ CAR-T Product Biologics License Application

– July 12, 2017

WASHINGTON, DC, July 12, 2017 – The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the gene and cellular therapies and broader regenerative medicine sector, has issued the following statement in response to today’s U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee meeting discussing Novartis’ biologics license application for tisagenlecleucel, the company’s anti-CD19 CAR-T product for the treatment of pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL):

The Alliance for Regenerative Medicine, as the leading advocate for cellular and gene therapies and the broader regenerative medicine sector, celebrates this major milestone. We couldn’t be more pleased and encouraged to see CAR-T products and other cell-based immuno-therapies moving ahead in the appropriately rigorous regulatory review process. These products offer extraordinary potential for patients and their families.

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee’s careful consideration of the data today and unanimous vote in favor of approval moves this product significantly closer to widespread accessibility. We look forward to continued updates on the progress of these transformative products and the substantial positive therapeutic impacts they stand to provide.

About The Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 265 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit