Bristol Myers Squibb's Reblozyl, chasing $4B sales target, wins key FDA label expansion

As Bristol lays off staffers and works through the painful loss of exclusivity for its megablockbuster blood cancer medicine Revlimid, the company is chalking up a win for its up-and-coming Reblozyl.

Thanks to a new FDA approval, Bristol's Reblozyl can be used as a first-line treatment for anemia in patients with very low- to intermediate-risk myelodysplastic syndromes who haven't received a prior erythropoiesis stimulating agent (ESA). The new nod also covers patients regardless of ring sideroblast status.

The FDA based the approval on results from the pivotal phase 3 COMMANDS trial. In the study, Reblozyl outperformed ESAs in this patient population, becoming the first drug ever to do so.

In the study, 58.5% of patients on Reblozyl reached red blood cell transfusion independence (RBC-TI) for at least 12 weeks, compared with 31.2% of patients treated with Amgen and Johnson & Johnson’s Epogen/Procrit (epoetin alfa).

Reblozyl also has an edge on the entrenched Epogen/Procrit alternative with its convenience factor. The BMS drug is dosed every three weeks, compared with the ESA’s weekly administration.

“Today's expanded approval of Reblozyl marks an important milestone in our commitment to MDS patients with anemia by providing a durable and more effective treatment option, with more convenient and less frequent administration,” BMS' senior vice president and general manager of U.S. hematology and cell therapy, Wendy Short-Bartie, said in a statement.

MDS are hallmarked by ineffective production of healthy red blood cells, white blood cells and platelets which can cause anemia and infections and often require blood transfusions. Frequent transfusions are linked to a higher risk of iron overload and patients who become dependent on red blood cell transfusions have a significantly shorter overall survival outlook.

About 30,000 patients are diagnosed with MDS yearly in the U.S. with more than half classified as lower-risk disease status.

This is Reblozyl's third U.S. approval in an anemia subgroup. The first-line use in MDS represents a key milestone as the company targets $4 billion in peak sales for the medicine.

Reblozyl is one of seven recently launched products that BMS hopes will reach $25 billion in collective sales by 2030. In the first half of 2023, the drug generated $337 million, up 21% from the same period last year.