Post by
askretka on Aug 08, 2021 8:26am
CAR-T is getting Competitive between big Pharmas too
Who ever buys ONC will get a ICI advantage and a possible big CAR-T advantage as well? ----------------- 17 Feb 2021 ------------- Bristol Myers' Breyanzi tunes its pitch for fight against entrenched CAR-T players Novartis and Gilead -----------------' After Breyanzi's long-and-winding path to an FDA approval, Bristol Myers Squibb is diving into the complex CAR-T lymphoma marketa 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' Breyanziwon its FDA green light inearly Februaryinadults with relapsed or refractory large B-cell lymphoma after at least two rounds of systemic therapy, the field where Gilead and Novartishave spent years buildingthe lead for their respectivemedicines. ------------------------ 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, SamitHirawat, M.D., saidin an interview. Many people "cant get them or dont 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 updigital temperature-tracking to help patients monitor their health after treatment. Despite the years-long head start forBreyanzisrivals, BMS believes its drug carries a differentiated profile,Hirawatsaid, with rapidly occurring responses and durable responses." In a pivotal study, the med posted a 73% overall response ------------------------- Breyanzi also doesnt 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 fourweeks. Side effects have been common in studies, but relatively few patients experienced severe side effects, Hirawat said. Patients typically dont have to return to treatment sites after receiving the medicine,Hirawatsaid, which could go a long way with facilities, patients and payers. To help patients monitor themselves forpotential side effects, the company is launching itsCell Therapy 360 program, which includes asmartphone 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, andHirawatsaid the company has an industry-leading CAR-T productionsite up and runningin Bothell.The company aims to bring another site online in New Jerseyto 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. Breyanzisfirst indication is only the companys 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.