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

2023-08-29

临床3期临床结果上市批准细胞疗法

The approval marks the third for the drug, which BMS picked up from its Celgene buy.

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

ThaBristola new FDA approval, Bristol's Reblozyl can be used as a first-line treatment for anemia in pablood cancervery 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 thFDApproval on results frReblozylivotal phase 3 COMMANDS trial. In the studyanemiaozyl outperformed ESAs in this patient populationmyelodysplastic syndromes ever to do so.

In tFDAstudy, 58.5% of patients on Reblozyl reached red blood cell transfusion independence (Reblozylfor 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 enReblozyl Epogen/Procrit alternative with its convenience factor. The BMS drug is dosed every three weeks, compared with the ESA’s weekAmgenminisJohnson & Johnson Procrit (epoetin alfa)

“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 cellMDSnd platelets whanemian 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.

MDSut 30,000 patients are diagnosed with MDS yearly in the U.S. with more than half classified as lower-risk disease statanemia infections iron overload

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

ReblozylReblozylof seven recently launched pranemia 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.

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