Posted from: Monday, June 04, 2018 - 10:03 AM - Present

New Indication for CAR-T Therapy Kymriah

May 1, 2018 – The U.S. FDA has approved a second indication for Kymriah® (tisagenlecleucel), manufactured by Novartis. The first-in-its-class CAR-T therapy is now approved to treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This includes adults with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Kymriah made headlines in 2017 when the FDA approved the product to treat patients up to 25 years of age who have relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). CAR-T therapies such as Kymriah use the patient’s own immune cells to battle cancer. T-cells, a type of white blood cell, are obtained from the patient and sent to a lab where they are engineered to attack cancerous cells. The modified cells are then infused back into the patient.

The most common form of non-Hodgkin lymphoma, DLBCL can be difficult to treat once patients have experienced a relapse or have not responded well to initial therapy. In these instances, prognosis is typically poor. Kymriah may offer such patients a chance for more effective treatment.

Novartis plans to use a controversial approach known as indication-based pricing for Kymriah. Under this pricing model, cost for the treatment will vary depending on what it is used to treat and the size of the patient population. At a wholesale acquisition cost (WAC) of $373,000 per dose, Kymriah for adults with lymphoma will run roughly $100,000 less per dose than for patients who receive the therapy under its ALL indication.

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Last Updated Wednesday, August 15, 2018 - 01:20 PM.