FDA Approves Yescarta for Non-Hodgkin Lymphoma

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults. Typically, it is treated by a type of chemotherapy called R-CHOP.

On October 18th, the FDA approved a different type of treatment for adults with diffuse large b-cell lymphoma who have relapsed after at least two other kinds of treatment.

This new treatment, Yescarta, is made from the patient’s own white blood cells that are engineered recognize and attack the lymphoma cells. Yescarta is the 2nd gene therapy approved by the FDA and the 1st for non-Hodgkin lymphoma.  

How is Yescarta given?

Yescarta will be available as an infusion given over a 30-min period. The infusion must be given at a certified healthcare facility and patients must be monitored daily for 7 days following the infusions.

Dosing for each patient will depend on their body weight.

Where will Yescarta be available?

Yescarta can only be given in an authorized treatment center. This is to ensure the safe use of Yescarta.

According to the press release from the manufacturer of Yescarta, Kite, 16 centers will soon be able to administer Yescarta infusions. Kite is also actively working to train more than 30 additional centers with an eventual target of 70 to 90 centers across the US.

The latest information on Yescarta authorized centers can be found on their website here.

Are there any serious side effects associated with Yescarta?

Yes. Yescarta has a boxed warning, the most severe warning a medication can have. Yescarta can potentially cause cytokine release syndrome, which can cause a high fever, flu-like symptoms, and life-threatening neurologic toxicities.

The most common side effects include serious infections, low blood cell counts, and a weakened immune system. Side effects typically appear within the first 1 to 2 weeks of treatment but may occur later in treatment as well.

Is there anything unique about Yescarta?

Yes. Yescarta is the 2nd gene therapy approved by the FDA and the 1st for certain types of non-Hodgkin lymphoma.

Yescarta is also the first CAR-T therapy (an abbreviation for the fancy term chimeric antigen receptor T-cell therapy). This type of therapy uses the patients own cells to detect and kill the cancer cells infecting their body. CAR-T therapy is specifically manufactured for each individual patient.

How much will Yescarta cost?

Here’s the not so good news. The list price of Yescarta in the US is $373,000. Not cheap.

Kite, the manufacturer, has created the KiteKonnect program to assist qualifying patients with the cost of Yescarta. For more information, and to find out if you qualify, visit the website here or call 1-844-454-5483.

Filed under