The Alliance for Regenerative Medicine has issued the following statement:
The FDA’s approval of Novartis’s CAR T-cell therapy Kymriah is a historic and monumental milestone for patients and the broader regenerative medicine sector. Great potential has become thrilling reality with the approval of what will likely be a cure for patients with B-cell acute lymphoblastic leukemia (ALL).
CAR T-cell therapies and other cell-based immuno-oncology technologies will transform the standard of care for many oncological indications, a huge area of medical need. According to our recently issued data report, 50 percent of clinical trials utilizing regenerative medicine technology, including cell or gene therapies, are in oncology. Nearly 900 trials are currently underway in cell and gene therapies and other regenerative medicine technologies across numerous indications.
We note with optimism the commitment CMS has made towards novel reimbursement arrangements, and we applaud FDA Commissioner Scott Gottlieb, M.D.’s recognition of and appreciation for gene and cell therapies.
We look forward to additional advances reaching the market. We anticipate many lives will be saved as a result.
The Alliance for Regenerative Medicine and its member companies and institutions, including many of the leading medical centers where these therapies will be administered, will be meeting over the coming weeks to discuss the profound impact this approval and others expected soon will have on the the practice of medicine. These discussions will guide our advocacy efforts as we work with all of the key stakeholder groups to make sure these therapies are available to as many patients as possible.
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 in 2009, 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 270 members and is the leading global advocacy organization in this field. To learn more about ARM or to become a member, visit http://www.alliancerm.org.