“The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee unanimously voted to recommend approval for CTL019, an experimental cancer drug that belongs to a class of drugs called CAR T-cell therapies, which is a form of immunotherapy that essentially takes control of the body’s T-cells and directs them to attack tumors,” Drug Discovery & Development.
“Timothy Cripe, a panel member who is an oncologist with Nationwide Children’s Hospital in Columbus, Ohio, called the treatment the ‘most exciting thing I’ve seen in my lifetime,'” The Washington Post.
“‘This is a major advance and is ushering in a new era in treating children,’ agreed Dr. Malcolm Smith, associate branch chief for pediatric oncology at the National Cancer Institute,” NPR.
“Validation came in the form of family testimonials during the meeting, when we heard the heart-wrenching stories of Emily and Connor. The audience was simply overwhelmed by the courage of these now young adults who had received CAR-T cells for their leukemia. Their parents shared stories of unfathomable numbers of tests, treatments and hospitalizations over the course of years in these young lives. ODAC audience members wiped away tears, both in empathy for these families and by the sense that a therapy could have such a dramatic impact both clinically and personally,” Forbes.
“Commenting after the vote, panel members emphasized the “clear” efficacy of the product and the fact that there is a strong unmet need for new therapies for relapsed/refractory ALL. One panel member, Alan Rein, PhD, from the National Cancer Institute, Bethesda, Maryland, highlighted the “remarkable clinical successes.” However, he also said that there are unanswered questions about long-term safety, so he was glad to see discussion of follow-up for 15 years,” Medscape.
