After getting the cold shoulder from regulators over its filing for CAR-T candidate ide-cel earlier this week, Bristol Myers Squibb at least has good news now for one of the products it acquired through its $74 billion Celgene buyout.
The FDA green-lighted Pomalyst in patients with Kaposi sarcoma, a rare form of cancer that usually presents as skin lesions but can also form in other parts of the body, such as the lungs or lymph nodes, BMS said. The med got the go-ahead in AIDS patients who are resistant to highly active antiretroviral therapy and in patients who are HIV-negative.
Previously, Pomalyst was approved only in multiple myeloma.
The drug snagged the agency’s favor after showing in a phase 1/2 study that it could provoke a response in 71% of patients and clear cancer completely in 14% of those patients. Half of patients Pomalyst helped continued to benefit past the one-year mark.
Because the study was a single-arm trial, BMS may have to show positive results in a confirmatory trial to keep its approval, but at least for now, patients will have their first oral therapy for Kaposi sarcoma—and the first new treatment option, period, in more than 20 years.
While the indication won’t be ultra-lucrative for Pomalyst—the disease affects just six people per million each year in the U.S., most of whom are immunocompromised, according to the New Jersey drugmaker—it’s a regulatory feather in the cap for BMS, which officially swallowed Pomalyst-maker Celgene late last year.
Unfortunately for Bristol—and its shareholders—it may be a while before the company can add a feather for ide-cel, one of two CAR-T therapies the deal hinged on. The FDA has refused to review the drugmaker’s submission for the multiple myeloma prospect, BMS said Wednesday, until parts of its approval filing are beefed up.
As for Celgene’s already approved drugs, though, they’re paying off for Bristol. In last year’s fourth quarter, its first as a combined company, BMS posted revenues of $7.9 billion that blew past analysts’ $7.1 billion consensus estimate, in part on the back of Pomalyst, whose sales swelled 23%.