Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The FDA has linked a risk evaluation and mitigation strategy with the approval: hospitals and their associated clinics that dispense axicabtagene ciloleucel need to be specially certified.
Diffuse large B-cell lymphoma is the most common type of the disease in adults, with some 72,000 new patients diagnosed annually in the U.S., according to the American Cancer Society, and some 20,000 will die from it this year.
"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", FDA Commissioner Dr. Scott Gottlieb said.
"We believe this is only the beginning for auto T therapies", Arie Belldegrun, MD, FACS, founder of Kite, said in a statement. Currently, patients with large B-cell lymphoma in second or later lines of therapy have poor outcomes and greater unmet need, since almost half of them either do not respond or relapse shortly after transplant. This is the first gene therapy to be approved for non-Hodgkin lymphoma (NHL), according to the FDA.
Three of every five cases of aggressive National Hockey League are the DLBCL variety.
Yescarta is approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of conventional therapy. "That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies". Returned to the patient, all the revved-up cells can continue multiplying to fight disease for months or years. "We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms". The FDA anticipates that more agents in this class will gain approval in the future and is taking steps to establish a system for evaluation of these adaptive T-cell therapies.
Gottlieb added that the FDA "will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine". FDA notes that treatment with axicabtagene ciloleucel can potentially cause serious adverse effects.
To start, a doctor removes some white blood cells, the part of our body's immune system responsible for combatting infections and foreign substances, from a patient.
"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). It is now working to train another 30 centers, with a goal of opening 70 to 90 Yescarta centers across the nation.
The Yescarta approval came 15 days after Gilead completed its approximately $11.9 billion acquisition of Kite (formerly Kite Pharma), a deal announced August 28, two days before Kymriah was approved.
For more on what role pharmacists can play for patients with lymphoma, view the video below.