Bristol Myers snares another approval from the old Celgene pipeline, nabbing an overlooked OK
Bristol Myers Squibb has gotten another approval from the old Celgene pipeline yesterday, this time for a once low-profile compound.
The FDA green-lighted Onureg, an oral drug previously known as CC-486. It’s chemically known as azacitidine — the same compound that in its IV form, branded as Vidaza, has long been used to treat acute myeloid leukemia and myelodysplastic syndromes. For Bristol Myers, it marks the second major approval since the Celgene merger was completed, after the multiple sclerosis drug Zeposia was OK’d earlier this year.
With three CVR drugs — ide-cel CAR-T, liso-cell CAR-T and Zeposia — grabbing the spotlight as the two sides hammered out merger talks last year, CC-486 received little press until the fall. But at ASH last December, the companies showed off overwhelmingly positive data vs. placebo from a Phase III trial in AML patients. In the 472-person study, median overall survival was 24.7 months for those in the treatment arm, 14.8 months for those on placebo.
The FDA granted priority review on May 1 off that data, and approved it just three months later.
The drug already has some proven market potential; at its peak, Vidaza brought in $600 million per year for Celgene, which acquired the compound in a $2.9 billion buyout of Pharmion in 2007. And in an editorial in Blood last March, Andrew Wei, an oncologist at Australia’s Monash University, said that if the CC-486 Phase III results were positive, maintenance therapy would “likely … be accepted as a new standard of care.”
On the other hand, patients now have more options than they did in 2007. For one, there’s Idhifa, the drug Agios and Celgene got approved three years ago and that Bristol Myers also picked up in the merger. Roche won an OK for Venclexta the following year, and they have an MDM2 inhibitor called idasanutlin that is now in Phase II studies.
Bristol Myers is also looking to expand the potential indication for the drug. Phase IIIs are ongoing testing the drug in lymphoma and MDS.