After Breyanzi's long-and-winding path to an FDA approval, Bristol Myers Squibb is diving into the complex CAR-T lymphoma market—a market already dominated by Gilead Sciences and Novartis therapies. Still, the company has worked up its talking points, an exec said, and has big plans for the road ahead.
BMS' Breyanzi won its FDA green light in early February in adults with relapsed or refractory large B-cell lymphoma after at least two rounds of systemic therapy, the field where Gilead and Novartis have spent years building the lead for their respective medicines.
But while the Novartis and Gilead CAR-T meds won their first approvals in 2017, patients still don't have "many options" if their disease relapses after second-line treatment, Bristol's chief medical officer, Samit Hirawat, M.D., said in an interview. Many people "can’t get them or don’t respond” to the other CAR-T options, he said, noting that another treatment is “needed.”
Job one for the Breyanzi launch is, of course, getting treatment centers up and running so patients have somewhere to go for their therapy. But Bristol Myers is also touting data that it says sets its drug apart from its rivals. And it's counting on Breyanzi's ability to treat people in outpatient clinics, rather than during a hospital stay. The company has even set up digital temperature-tracking to help patients monitor their health after treatment.
Despite the years-long head start for Breyanzi’s rivals, BMS believes its drug carries a “differentiated” profile, Hirawat said, with “rapidly occurring responses” and “durable responses." In a pivotal study, the med posted a 73% overall response rate and a 54% complete response rate.
Breyanzi also doesn’t require patients to “sequester” in hospitals,” the exec said. Under an FDA-ordered risk-management plan, treatment centers need to be certified, with staff trained to administer the therapy and recognize side effects. The centers will follow patients closely for a week, and patients need to stay close by for four weeks. Side effects have been common in studies, but relatively few patients experienced severe side effects, Hirawat said.
Patients typically don’t have to return to treatment sites after receiving the medicine, Hirawat said, which could “go a long way” with facilities, patients and payers.
To help patients monitor themselves for potential side effects, the company is launching its Cell Therapy 360 program, which includes a smartphone app and a disposable patch that senses body temperature. The program's website includes resources for healthcare providers as well as patients, including 24/7 on-call support.
CAR-T treatments are notoriously tough to manufacture, and in that arena, BMS stumbled last year on its way to an eventual approval. Separate FDA inspections spotted issues at a BMS plant in Bothell, Washington, and a Lonza viral vector plant in Houston.
Now, though, BMS is set for its rollout, and Hirawat said the company has an industry-leading CAR-T production site up and running in Bothell. The company aims to bring another site online in New Jersey to produce commercial and clinical supplies.
On the sales front, the company will have some catching up to do: Gilead's Yescarta pulled in $563 million worldwide last year, while Novartis' Kymriah generated $474 million.
Breyanzi’s first indication is only the company’s “foray” into the field, the exec said, noting BMS has a “large development plan following right behind” the initial use. Ide-cel, an investigational CAR-T treatment for multiple myeloma, is up for an FDA decision in March.