Bristol Myers Squibb (BMY -0.53%) and bluebird bio (BLUE 13.37%) recently gained Food and Drug Administration approval of Abecma. In this video from Motley Fool Live, recorded on March 29, Fool.com Contributors Brian Orelli and Keith Speights discuss the prospects for Abecma and what the companies are doing to increase the potential market for the chimeric antigen receptor T-cell (CAR-T) product.
Brian Orelli: On Friday, the FDA approved Bristol Myers Squibb and Bluebird Bio's CAR-T treatment for multiple myeloma. It targets BCMA. The treatment used to go by the code name ide-cel, and now the brand name is Abecma, A-B-E-C-M-A. They got that BCMA into the name. They're pricing it at $419,500. This is the first non-CD19 CAR-T to be approved, which is exciting, but it's approved to treat after the patient has already had four more therapies. We're talking about a fifth-line indication. What's the size of the market at that point, and then what are Bristol Myers Squibb and Bluebird doing to get the drug moved into earlier stage?
Keith Speights: First, Brian, this one has been a long time coming. I think it was last May, Bristol Myers Squibb and Bluebird received a refusal-to-file letter from the FDA. But the company's managed to address the FDA's issues pretty quickly and were able to refile pretty quickly. Now they've won approval.
Normally you would think a fifth-line treatment would have little to no commercial prospects. You would think this drug is going to be the drug of last resort and there are not going to be very many patients that take it, so it's going to a be very small market opportunity. With multiple myeloma, though, most patients relapse after receiving their initial therapies. What happens is the patients work their way through different classes of drugs. They'll take one therapy and its effectiveness tapers off, they relapse, and then the doctors prescribe the next drug class. They work their way through the therapy. I think with this particular disease, there's going to be a market opportunity even as a fifth-line treatment.
However, Bristol Myers Squibb and Bluebird obviously are going to have a much better and bigger market opportunity if they can win approval for the drug in the earlier-line settings, and that's exactly what they hope to do. They are evaluating it as a third-line treatment in a phase 3 study, evaluating it as a second-line treatment for multiple myeloma in a phase 2 study, and as first-line treatment in a phase 1 study. It's easy to remember -- third line, phase 3; second line, phase 2; first line, phase 1. They're hoping to ultimately get the drug approved in all settings, and when they do, this is going to be a really big market opportunity. This is a drug that was high on the list when Bristol Myers Squibb started to make some deals and start to partner with Bluebird. I think they have really high hopes for it.
Orelli: I think this one came from Celgene.
Speights: Celgene actually made the original deal. It was one of several in Celgene's pipeline that BMS really liked. I think this one actually was part of that contingent value that ended up... [laughs]
Orelli: It was the third one.
Speights: Yeah. They ended not panning out.
Orelli: It made it by the deadline, but the second one didn't.
Orelli: Yeah. The one before this one didn't.
Speights: Liso-cel was another CAR-T therapy in that group.