Novartis CAR-T Cell Therapy Receives FDA Approval for Third Indication to Treat Follicular Lymphoma

Swiss pharmaceutical company and chimeric antigen receptor (CAR) T cell pioneer, Novartis, announced that its CAR-T cell therapy, Kymriah, received FDA approval to treat adult patients with relapsed or refractory follicular lymphoma in the drug’s third indication. Kymriah’s first indication was relapsed/refractory diffuse large b-cell lymphoma, followed by b-cell acute lymphoblastic lymphoma, which received approval for adult and pediatric use, making it the only CAR-T cell therapy approved in adult and pediatric settings. 

Conquering Kymriah’s Third Indication for Follicular Lymphoma

Follicular lymphoma (FL) is a form of non-Hodgkin lymphoma (NHL), which is cancer in the lymphatic system. FL is typically slow-growing and often not an immediate threat to patients. Patients often go undiagnosed for several years without serious side effects. Though many cases of FL do not pose an immediate danger for patients, about 2-3% of FL cases each year progress into a more aggressive behaving subtype of NHL, most often large B-cell lymphoma. 

Novartis designed Kymriah to treat relapsed or refractory FL, meaning the disease has either gone into remission and come back, or the disease does not respond to treatment. Novartis said that data from its Phase 2 ELARA trial showed that 68% of the 90 participants achieved a complete response, and 86% achieved at least a partial response. Novartis also touted the prolonged response, stating that of those who achieved complete response, 85% maintained complete response after 12 months. A complete response is a complete disappearance of all signs of cancer, though the National Cancer Institute states this does not always mean that cancer is cured. 

Stephen J. Schuster, MD, the investigator on the trial, said, “Patients with follicular lymphoma who relapse or don’t respond to treatment have a poor prognosis and may face a series of treatment options without a meaningful, lasting response. This new, effective option for patients with follicular lymphoma may offer long-term benefit.”

Related Article: Stanford Touts Remote-Controllable CAR-T Cell Therapy

Blazing the CAR-T Cell Therapy Trial

CAR-T cell therapy is an individualized treatment that alters a patient’s cells in their immune system to help fight cancer. In the grand scheme of medicine, CAR-T cell therapy is relatively new. Israeli scientists Zelig Eshhar and Gideon Gross developed the first engineered T-cell with a chimeric molecule in the late 1980s to early 1990s. It took some time for the rest of the science community to catch up, but in time, modified T-cells showed promise as the future of immunotherapy.

After several decades of development, Novartis stepped up to the plate with Kymriah in 2017, which received the FDA’s first-ever CAR-T cell therapy approval. Since then, Novartis has been working around the clock to expand its indications to better serve those suffering from lymphatic cancers. 

Since Novartis laid the foundation in 2017, the FDA has approved four other CAR-T cell therapies. Companies competing with the Swiss giant are Bristol Myers Squibb with its Abecma and Breyanzi and Gilead Sciences with Tecartus and Yescarta. Only five drugs are on the market, but hundreds of other companies, researchers, and institutions invest time, money, and effort into developing CAR-T cell technology. 

Kymriah’s most recent FDA approval is another notch in the belt for Novartis in its CAR-T cell development journey. As Novartis continues to develop life-altering technology, the world will continue to keep watch on the growth of CAR-T cell development. 

Author

Reed Slater