Kymriah Indications Approved by FDA

Kymriah Indications Approved by FDA

Kymriah has received approval from the FDA for three primary indications:

1. B-cell precursor acute lymphoblastic leukemia (ALL): Approved on August 30, 2017, for patients up to 25 years of age with B-cell precursor ALL that is refractory or in second or later relapse. This type of leukemia affects the body’s immune system and is most commonly seen in children and young adults but can also occur in older adults.

2. Large B-cell lymphoma: Approved on May 1, 2018, for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This type of non-Hodgkin lymphoma affects the lymphatic system, which helps fight infections and diseases.

3. Follicular Lymphoma: On May 27th, 2022, the FDA expanded Kymriah’s use to include adult patients with refractory follicular lymphoma who have received at least two prior therapies. Follicular lymphoma is a type of indolent non-Hodgkin lymphoma that often follows a relapsing and remitting course. This approval was based on a clinical trial that demonstrated an overall response rate of 49%, with 38% of patients achieving a complete response.

Each of these indications represents a significant advancement in the treatment of these respective cancers, offering new hope and potential for long-term remission for many patients. As with any treatment, it is crucial for patients to discuss their options with their healthcare provider to understand the potential benefits and risks associated with Kymriah.