Jakavi treats a potentially life-threatening condition which often effects transplant patients
Novartis has announced the European Commission (EC) approval of Jakavi (ruxolitinib) for the treatment of patients aged 12 years and older with acute or chronic graft-versus-host disease (GvHD).
GvHD is a condition that may occur following an allogenic stem cell transplant, a transplantation in which patients receive stem cells from donors, or donated umbilical cord blood. GvHD occurs when the T cells donated view the patient’s healthy cells as foreign and begins to attack and damage them. In some cases, the disease can be life-threatening.
Around 50% of allogenic stem cell transplant patients will develop either acute or chronic GvHD, both of which can be fatal. Until now, both forms of GvHD had lacked an established standard-of-care for patients who did not adequately respond to first-line steroid treatment.
The EC has approved Jakavi for patients who have received inadequate response to corticosteroids or other systemic therapies. The approval follows the positive opinion granted in March by the Committee for Medicinal Products for Human Use of the EMA, based on results from phase III REACH2 and REACH3 trials.
“Today, 30-60% of patients with GvHD do not respond to first-line steroid treatment, underscoring the need for new approaches to ensure long-term treatment goals are met,” commented Dr Robert Zeiser from University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation in Germany.
“The approval of Jakavi offers healthcare providers and patients with GvHD who remain dependent on or refractory to steroids a new way to manage this debilitating and life-threatening condition,” he added.
Symtoms of GvHD can appear in the skin, gastrointestinal tract, liver mouth, eyes, genitals, lungs and joints. Currently, no other approved therapies exist for the treatment of GvHD after steroid failures.
“Five out of ten patients who receive allogeneic stem cell transplants experience the serious and sometimes fatal symptoms of graft-versus-host disease,” concluded Marie-France Tschudin, Novartis President of Innovative Medicines International and Chief Commercial Officer. “Jakavi, with this new indication in GvHD, will help to redefine treatment for patients who do not respond to first-line care.”
