Yescarta was approved after a rolling Biologics License Application (BLA) submission completed March 31. The FDA has approved a risk evaluation and mitigation strategy (REMS) for Yescarta that will inform and educate health care professionals about its associated risks.
"The FDA approval of Yescarta is a landmark for patients" who qualify for the treatment, which is aimed at patients with the non-Hodgkin's form of the blood cancer who had other unsuccessful treatments, Kite founder Dr. Arie Belldegrun said in a statement. "In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer", said Food and Drug Administration Commissioner Scott Gottlieb in a statement. It's described as gene therapy because the patient's own immune cells are removed and genetically engineered to better fight off the cancer. Kite's therapy is for patients with three types of aggressive, or fast-growing, large B-cell lymphoma.
The therapy has been dubbed a "living drug" by researchers and is the second in a new class of such therapies to win the federal go-ahead. This is the first gene therapy to be approved for non-Hodgkin lymphoma (NHL), according to the FDA.
Status orange wind warning issued for parts of the country
Some transport disruption was "likely", with delays to road, rail, air and ferry transport all possible, the warning added. The devastation from Ophelia left 360,000 people without power which was a result of trees falling onto power lines.
About 3,500 Americans each year could be candidates for Yescarta, a one-time intravenous infusion that is individually manufactured for each patient at a cost of $373,000. "That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies".
Dr. David Maloney, medical director of cellular immunotherapy at Fred Hutchinson Cancer Research Center, helped develop the therapy and said the FDA's second approval of a CAR-T cell therapy "validates the revolution underway in the field of cellular immunotherapy". "We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms".
A clinical trial involving more than 100 adult patients established the safety and efficacy of Yescarta. Also, patients must be informed of the potential serious side effects and of the importance of promptly returning to the treatment site if side effects develop. Serious adverse reactions occurred in 52% of patients and included CRS, neurologic toxicity, prolonged cytopenias (including neutropenia, thrombocytopenia, and anemia), and serious infections. Kite expects to certify 16 centers quickly and is actively working to train more than 30 additional centers, with an eventual target of 70 to 90 centers across the United States.
Lego's official 'Women of NASA' set goes on sale November 1
A new LEGO set honoring the pioneering women of NASA , including Chicago native Mae Jemison , will go on sale November 1. Female NASA pioneers Margaret Hamilton , Katherine Johnson , Sally Ride , Nancy Grace Roman and Mae Jemison in Lego form.
Yescarta is approved for adults for whom at least two other types of treatment have failed.
"Today is an important day for patients with relapsed or refractory large B-cell lymphoma who have run out of options and have been waiting for new treatments that may help them in their fight against cancer", Gilead Sciences President and CEO John Milligan said in a press release (Gilead owns Kite as of 2016).
For more on what role pharmacists can play for patients with lymphoma, view the video below.
Ford recalls 1.3M F-150, Super Duty trucks in North America
The recalled vehicles are model years 2015, 2016 and 2017 F-150 pickups, along with model year 2017 Super Duty pickups. Customers will be notified by letter to let them know they are part of the recall beginning the week of November 13.