Dive Brief:

• The Food and Drug Administration will decide whether to approve Bristol Myers Squibb’s cancer cell therapy Breyanzi for earlier use by late June, the company announced Thursday, indicating that the agency granted an expedited “priority review.”

• Breyanzi, a so-called CAR-T therapy, is currently cleared to treat relapsed or refractory large B-cell lymphoma in patients who have already received at least two other medicines. Study results presented last year, however, showed Breyanzi outperformed standard treatment when given earlier, after only one previous drug therapy, leading Bristol Myers to apply for an expanded approval.

• The decision date of June 24 set by the FDA is just under three months after the regulator is set to make a similar ruling on second-line use of Gilead’s rival CAR-T therapy Yescarta in large B-cell lymphoma.

Dive Insight:

CAR-T cell therapy, a technically complex drug built from the immune cells of individual cancer patients, has become a common option for people whose lymphoma has grown resistant or returned after other treatments.

Four are now approved in the U.S. for later-line treatment of lymphoma, three of which are cleared for diffuse large B-cell lymphoma, the most prevalent type. Their makers, however, have been studying use of CAR-T earlier, when patients are less sick and could potentially benefit for longer from cell therapy.

Last year, studies from Gilead and Bristol Myers demonstrated that potential convincingly. Results from each company showed their respective CAR-T treatments could significantly cut the risk of cancer progression, need for subsequent therapy or death compared to chemotherapy and a stem cell transplant, currently the go-to second-line option.

Stephan Grupp, director of the cancer immunotherapy program at the Children’s Hospital of Philadelphia who’s studied CAR-T therapies extensively, called the data “a major step forward in the field,” in a December 2021 interview with BioPharma Dive.

With positive results in hand, both companies have now asked the FDA to expand the labels for their treatments. The agency granted each application priority review status, which will shorten the evaluation for both of them.

Approvals would significantly expand the number of patients eligible for CAR-T therapy in the U.S., giving doctors more options for patients who may not be eligible or good candidates for stem cell transplant.

But broader use could also bring greater attention to the challenges of CAR-T therapy, which is personalized and manufactured for each individual patient. Gilead and Bristol Myers need two to three weeks to turn around a finished treatment, potentially complicating patient care.

And both therapies, while meant to deliver a long-lasting benefit after a single infusion, are costly: Gilead priced Yescarta at $373,000 per patient, while Bristol Myers set Breyanzi’s price at about $410,000. Insurance coverage has improved for later-line CAR-T use, but there may initially be hurdles to reimbursement for earlier treatment.

Sales of Yescarta in the U.S. totaled $106 million in the fourth quarter of last year, while Breyanzi earned Bristol Myers $38 million in the U.S.