Approval of lisocabtagene maraleucel (Breyanzi) for the patients with large B-cell lymphomas

March 5, 2021

In February, 2021, the FDA has approved lisocabtagene maraleucel (liso-cel; Breyanzi) for the patients with large B-cell lymphomas whose cancer has progressed after multiple therapies. The target cancer includes diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma.

​

Lisocabtagene maraleucel is a chimeric antigen-receptor (CAR)-T cell therapy which targets the protein called CD-19 in cancer cells. For more information about CAR-T cells, please read the post on Aug. 20, 2020.

This approval is based on the data from the phase 1 trial, TRANSCEND (NCT02631044). Seventy three percent of the patients in the trial was responded to liso-cel within 1 month, with 53% of the patients showing complete response to the drug, and 54.7% of the responders continued to respond to the drug at 12 months.

​

Incidents of common adverse effects of CAR-T cell therapy, severe cytokine release syndrome (CRS) and neurologic events were low with liso-cel. Only 1% of the patients had severe CRS (Grade 3 & 4) CRS, and only 10% of participants experienced severe neurologic effects.

​

What a remarkable development!

​

The trials is still recruiting patients for further studies. Please discuss your oncologists or contact us at minji@MJpatientadvocate.com to check your eligibility.