Orencia is a selective costimulation modulator that disrupts the continuous cycle of T-cell activation and was approved for several indications
Bristol-Myers Squibb site at Reeds Lane, Moreton, Wirral, England. (Credit: Rept0n1x/Wikipedia.)
Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Orencia (abatacept), in combination with calcineurin inhibitor and methotrexate to prevent acute graft versus host disease (aGvHD).
The regulator indicated the treatment for adults and paediatric patients aged two years and above, undergoing hematopoietic stem cell transplantation (HSCT) from an unrelated donor.
Acute GVHD is a potentially fatal complication caused when donor bone marrow or stem cells attack the graft recipient and impacts up to 70% of stem cell transplant patients.
Orencia is a selective costimulation modulator that disrupts the continuous cycle of T-cell activation, previously approved in the US for several indications.
The drug was approved to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and now prophylaxis for aGVHD.
Bristol Myers Squibb US immunology senior vice president Tina Deignan said: “Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant.
“With this fourth indication for Orencia, Bristol Myers Squibb draws on its legacy and expertise in both immunology and haematology to deliver an important treatment option for patients in a disease with high unmet need.”
The FDA approval is supported by results from two clinical trials, including the Phase 2 GVHD-1 trial, also known as ABA2, and a clinical study known as GVHD-2.
GVHD-1 was a multicentre, two cohort study in patients aged six years and above, who had undergone HSCT from a matched or 1 allele-mismatched URD.
It evaluated Orencia in combination with a regimen comprising cyclosporine or tacrolimus (CNI) and MTX for prophylaxis of aGvHD in HSCT patients.
GVHD-2 was designed to assess Orencia in combination with CNI and MTX for prevention of aGvHD in HSCT patients aged six years and above, compared to CNI and MTX alone.
The study leveraged data from the Centre for International Blood and Marrow Transplant Research (CIBMTR).
Orencia is not recommended with other immunosuppressives, as it is linked to increased risk of infection, hypersensitivity, interactions with immunizations and immunosuppression.
CIBMTR associate scientific director Steven Devine said: “With Orencia’s approval as a preventive option for aGvHD following unrelated donor HSCT, we hope hematopoietic stem cell transplant becomes a more accessible option for more patients.
“This may include patients of diverse ethnicities, who often have lower likelihoods of finding matched donors.”
The US FDA reviewed the data under its Project Orbis initiative, which enabled simultaneous review with the health authorities in Canada, Switzerland and as a pilot in Israel.