FDA Approves Yescarta, Agency's Second CAR-T Gene Therapy Approval

Gilead gains 4% after FDA approves lymphoma drug

UPDATED: FDA follows through with a groundbreaking OK for Yescarta, Gilead's new CAR-T breakthrough

Adults with relapsed or refractory non-Hodgkin lymphoma (NHL) now have new hope. To treat these events, 43% of patients received tocilizumab and 27% received corticosteroids.

A wave of new cancer treatments that reprogram a person's own cells to fight cancer is gaining momentum.

The manufacturing site has capacity to produce volumes of the autologous therapy for 4,000-5,000 patients per year, but now Yescarta has been approved Gilead said it is looking to ramp up the number of clinics available to administer the therapy. The treatment will cost almost $375,000, which is $100,000 less than the first FDA-approved CAR-T treatment.

In a clinical trial of more than 100 adults, 51% of patients treated with Yescarta achieved complete remission, far higher than what is normal with present standard-of-care treatments. The boxed warning also includes a warning for neurologic toxicities.

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Gilead, which is based in Foster City, Calif., and previously has been criticized for high prices for its hepatitis C drugs, could face scrutiny for the $373,000 price of Yescarta, although that was less than the $475,000 that some analysts had expected. Commissioner Scott Gottlieb announced alongside the approval that FDA will soon issue a comprehensive agency policy clarifying how FDA's expedited programs apply to gene therapy products. The therapy was approved for treating certain types of large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma).

The Food and Drug Administration has approved the first chimeric antigen receptor T cell, or auto T, therapy for patients with certain types of lymphoma.

The market capitalization of Gilead is now reeling at 104.65B based on its aggregate value over its current share price and the total amount of outstanding stocks. The FDA is requiring Kite to do a long-term safety study and train hospitals to quickly spot and handle those reactions. Other side effects include infections, low blood cell counts, and dampened immune system.

Dr. Arie Belldegrun, founder of Kite, recognized "the FDA for their ability to embrace and support transformational new technologies that treat life-threatening illnesses".

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Similar CAR-T therapies are being developed by Juno Therapeutics Inc., Bluebird Bio Inc., and others.

Yescarta is a chimeric antigen receptor T cell therapy.

People with advanced lymphoma now have another type of treatment to consider.

The treatment was first developed at the National Cancer Institute, led by Dr. Steven Rosenberg, who signed an agreement with Kite Pharma in 2012.

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He said the advancement of cell therapy research, which produced Yescarta, will help bring more options to patients with other forms of cancer. The therapy is still working in most study participants, so the average duration of its effects isn't known yet.

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