Bristol Myers’ leukemia hopeful snags speedy FDA review

Bristol Myers’ leukemia hopeful snags speedy FDA review

Exactly one month after filing its multiple myeloma CAR-T for FDA approval, Bristol Myers Squibb is at it again. It’s nabbed priority review status for another blood cancer program it picked up from Celgene: a leukemia treatment aimed at keeping patients in remission. The FDA is set to make a decision by Sept. 3.

The filing is based on phase 3 data revealed in December showing the drug, CC-486, beat placebo at extending the lives of patients with acute myeloid leukemia (AML). The study pitted CC-486 against placebo in 472 patients whose cancer had disappeared after front-line treatment but who could not receive stem cell therapy—or chose not to. Some of those patients whose cancer disappeared had lower-than-normal levels of some blood cells, which is linked to worse outcomes than those who achieve complete remission.

The drug extended patients’ lives a median of two years (24.7 months) versus 14.8 months for those on placebo. It also staved off relapse for twice as long as placebo—patients taking CC-486 stayed in remission for a median 10.2 months compared to 4.8 months for patients on placebo. The results were consistent across the treatment group, including the patients with low levels of some blood cells.

The most common side effects of the drug were nausea, vomiting and diarrhea. Patients taking CC-486 and placebo experienced low blood platelet counts and anemia at roughly the same rate, while more patients taking the drug had neutropenia, or a low white blood cell count. Patients stayed on treatment until “unacceptable toxicity” or their cancer got worse, with 13% of CC-486 patients and 4% of placebo patients quitting the study because of side effects.

Adults with newly diagnosed AML often beat back their cancer with their first-line treatment, but many patients will relapse, said Noah Berkowitz, M.D., Ph.D., who leads global clinical development at Bristol Myers’ hematology unit, in a statement.

“Patients in remission are seeking treatment options that decrease the likelihood of relapse and extend overall survival,” he said.

Bristol Myers’ $74 billion bet on Celgene keeps on delivering. After two years without a new drug approval, BMS got two in 2019 for hematology assets picked up in that deal: myelofibrosis drug Inrebic and Reblozyl, which treats anemia in patients with beta thalassemia. And just last month, the company filed its anti-BCMA CAR-T therapy with the FDA, the third of a trio of assets that could trigger a major payout to Celgene investors.

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