Bristol-Myers Squibb (BMS) has received breakthrough device designation for its Orencia (abatacept) drug to prevent moderate to severe acute graft-versus-host disease (GvHD).
The drug is meant to prevent the disease in haematopoietic stem cell transplants from unrelated donors.
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GvHD is said to be a life-threatening complication known to affect patients receiving transplants for select genetic diseases and haematologic cancers.
Orencia is an immunomodulator designed to interrupt the continuous T-cell activation cycle, a characteristic of rheumatoid arthritis. The drug is already indicated to treat adult rheumatoid arthritis, juvenile idiopathic arthritis and adult psoriatic arthritis.
Breakthrough therapy designation to prevent GvHD comes from results of an investigator-initiated Phase II clinical trial that evaluated the drug as an adjunct to a standard GvHD prophylactic regimen for preventing the severe acute form of the disease.
Supported by BMS, the trial enrolled patients with haematologic malignancies undergoing a transplant of stem cells obtained from an unrelated, human leukocyte antigen (HLA)-matched or mismatched donor.
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By GlobalDataBristol-Myers Squibb Orencia development lead Brian Gavin said: “We are excited about the potential of Orencia to improve outcomes for patients receiving unrelated stem cell transplants.
“We believe the data could lead to an expansion of the donor pool for stem cell transplants in some patient populations where fully matched unrelated donor transplants have rarely been available.
“We look forward to working with the FDA and making Orencia the first approved therapy for the prevention of acute GvHD.”
Also, BMS and its partner Acceleron Pharma announced that the FDA Oncologic Drugs Advisory Committee agreed to review the supplemental biologics license application (sBLA) of Reblozyl to treat myelodysplastic syndromes (MDS).
Previously, the FDA approved the drug to treat anaemia in adults with beta thalassemia who require regular RBC transfusions.
BMS is now seeking approval for adults suffering from anaemia related to very low to intermediate-risk MDS. The drug is intended for patients with ring sideroblasts who require red blood cell (RBC) transfusions.
