CTI BioPharma has obtained Israeli Ministry of Health’s approval for Pixuvri (pixantrone), as a monotherapy to treat adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin’s lymphoma who have received up to three previous courses of treatment.
The company also announced that the Dutch Healthcare Authority and the College voor zorgverzekeringen of the Netherlands have approved funding for Pixuvri as an add-on drug for patients who need a third or fourth-line treatment option for aggressive B-cell lymphoma.
Tel Aviv University faculty of medicine Dr Abraham Avigdor said: "The approval of PIXUVRI in Israel provides patients with aggressive B-cell NHL who have failed second or third-line therapy a new approved option, where none existed before, that can effectively treat their disease with manageable side-effects.
"Patients who have relapsed after second-line therapy have a poor survival outcome.
"It is vital to have additional treatment options available, like Pixuvri, so we can provide these patients the best care possible and help them battle their disease."
CTI BioPharma said that the benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
Neopharm will distribute and market Pixuvri, an aza-anthracenedione, in Israel once the drug is included in the Israeli National Health Basket of drugs by the Ministry of Health.
Pixuvri was approved by the European Commission in May 2012 as a monotherapy for treatment of adult patients with relapsed or refractory aggressive B-cell NHL.