Kymriah Approval Date

Kymriah Approval Date

Introduction to Kymriah

Kymriah (tisagenlecleucel) is a groundbreaking chimeric antigen receptor T-cell (CAR-T) therapy developed by Novartis. It represents a novel approach to cancer treatment by using the patient’s own genetically modified T-cells to target and kill cancer cells. Kymriah is specifically designed for certain types of blood cancers and has shown remarkable efficacy in clinical trials, offering a new hope for patients with otherwise limited treatment options.

FDA Approval Dates and Indications

1. B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Kymriah was first approved by the U.S. Food and Drug Administration (FDA) on August 30, 2017. This initial approval was for the treatment of pediatric and young adult patients (up to 25 years of age) with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

2. Relapsed or Refractory Large B-cell Lymphoma

On May 1, 2018, Kymriah received its second FDA approval, this time for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, after two or more lines of systemic therapy.

3. Follicular Lymphoma

Most recently, on May 27, 2022, Kymriah was approved by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This expanded the use of Kymriah, demonstrating its efficacy in another subtype of lymphoma.

Summary of FDA Approvals

– August 30, 2017: Approval for pediatric and young adult patients (up to 25 years) with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.

– May 1, 2018: Approval for adult patients with relapsed or refractory large B-cell lymphoma, including DLBCL, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, after two or more lines of systemic therapy.

– May 27, 2022: Approval for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

Kymriah’s approvals mark significant milestones in the field of immuno-oncology, providing patients with new treatment options that harness their own immune systems to fight cancer.