In this video from Motley Fool Live, recorded on Jan. 4, Corinne Cardina, bureau chief of healthcare and cannabis, and Fool.com contributor Brian Orelli discuss upcoming decisions by the Food and Drug Administration (FDA) that Bristol Myers Squibb (BMY +0.12%) faces. But the potential regulatory approvals are more likely to affect the pharma's biotech partners than Bristol Myers Squibb itself.
Corinne Cardina: So let's talk a little bit about Bristol Myers Squibb. This company has a few upcoming FDA decisions for its cancer drugs. These decisions are, of course, going to affect its partners. Can you tell us what to expect for Bristol Myers in terms of FDA deadlines?
Brian Orelli: Yeah. So they have ide-cel, which is a CAR T, so that's -- they take cells out of the patient, you train them to attack the cancer, then you put them back in. This is for relapsed and refractory multiple myeloma, which is a blood cancer. The FDA's supposed to make a decision on or about or before March 27th. I think it's probably a fairly small market opportunity because they won't be in the first-line, so that's what the relapsed and refractory means. So relapsed means that you took a different drug and then failed it. Or you took a different drug, it worked and then you failed in refractory, it just means you took a different drug, you either couldn't tolerate it or it didn't work at all.
Cardina: This is with Bluebird [Bio] (BLUE +0.00%), right?
Orelli: Yeah. This is with Bluebird Bio. Then I know there's also manufacturing constraints because as we said, you have to make it individually for each individual patient because you have to take the patient cells out, train them, and then put them back in.
Bristol Myers also has Opdivo, which is a cancer drug. They've tested with Exelixis' (EXEL +0.05%) Cabometyx in first-line renal cell carcinoma, that's kidney cancer. The PDUFA date there is February 20th. I think it's probably a bigger opportunity for Exelixis than it is for Bristol Myers because Opdivo's already approved in the first-line setting. But Exelixis' Cabometyx is improved in the second line setting. It'll allow Exelixis to get access to more patients. Although the combination works better than Opdivo by itself and so the advantage there -- Bristol Myers should be able to take some market share from the rest of the competitors in the first-line space by adding Cabometyx. Bristol Myers will get some benefit, but I think it's a bigger opportunity for Exelixis.
Then liso-cel, we're still waiting for an approval. This is another CAR T for large B cell lymphoma. It was supposed to be approved last year, but the FDA delayed its inspections. It's part of that contingent value right that Celgene shareholders got and the deadline for that was the end of last year. It appears that's not going to pay out, although they're probably getting some lawsuits, and eventually, we might see Bristol Myers settle and offer less money to payout for the contingent value right than they would have if it had gotten approved by the deadline.
Cardina: Yeah. It's definitely disappointing to anyone holding that security.
