FDA’s Approval of Breyanzi Gives Some Patients With Lymphoma a ‘Life-Saving Therapy', Says Expert


The FDA approval of Breyanzi, a novel CAR-T cell therapy, provides many patients with lymphoma a new treatment option that can be used earlier in the course of their disease, according to an expert.

The June 2022 Food and Drug Administration (FDA) approval of Breyanzi (lisocabtagene maraleucel) for previously treated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3, will give patients who are not eligible for transplant a new treatment option that could be lifesaving, according to Dr. Nilanjan Ghosh.

Ghosh, who is the director of the Lymphoma Program at Levine Cancer Institute in Charlotte, North Carolina, and a researcher on the clinical trial that led to Breyanzi’s approval, recently discussed what the FDA approval means for patients with the disease.

“This approval will allow this life-saving therapy to be used earlier in the course of the disease (after failure of frontline therapy),” he said in an interview with CURE®.

Breyanzi is a CAR-T cell therapy, meaning that it redirects T cells (which are part of the immune system) to recognize and eliminate cells that express CD19 antigen, which is often found on B-cell cancerous cells. And, unlike other treatments that may need to be repeated, patients only need to be treated with CAR-T cell therapy once.

“Breyanzi is a one-time treatment,” Ghosh explained. “Patients who achieve a complete response (no traces of cancer left after treatment) often have sustained remissions. Most importantly, this treatment can work even in patients who are refractory to chemotherapy.”

While CAR-T cell therapies like Breyanzi have elicited promising results for some patients, there are potential side effects — namely cytokine release syndrome and neurotoxicity — and other considerations that patients need to know about and discuss with their care team, according to Ghosh.

“Patients need to understand the (side effects) associated with Breyanzi and the close monitoring need,” he said. “They also need to live in proximity to the certified health care facility where Breyanzi is administered for at least four weeks following infusion, and they also need to refrain from driving or hazardous activities for at least eight weeks following the infusion. They should also have caregiver support.”

Ghosh noted that in the clinical trial that led to Breyanzi’s approval, instances of cytokine release syndrome (a condition where the patient’s body releases too many inflammatory molecules) and neurotoxicity (damage to the nervous system, which can result in cognitive or behavioral changes) tended to be low-grade, meaning of minimal severity. The treatment was mostly well-tolerated, according to Ghosh, even in older patients with other health complications.

Since Breyanzi and other CAR-T cell therapies are vastly improving outcomes for patients with blood cancers, expanding access to these treatments is a critical next step, according to Ghosh.

“We need to improve access to CAR-T cell therapy so that most patients with relapsed or refractory large B-cell lymphoma can benefit from this treatment,” he concluded. “We need to expedite financial clearance for CAR T, increase the availability of slots for T cell collection, cut down manufacturing times and find effective measures to keep the disease controlled while patients are waiting to get their CAR-T cell therapy.”

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