BRIEF—CHMP recommends upgrading Servier's conditional Pixuvri approval

Some seven years after a conditional approval, Pixuvri (pixantrone) is on the brink of gaining a full authorization in Europe as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the Servier drug in this indication, which is usually the sign for an upcoming approval within weeks. Its progress in Europe contrasts with poorer fortunes in the USA, where Pixuvri is not approved.

"Patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma have limited treatment options,” said Pier Luigi Zinzani from the University of Bologna Institute of Hematology and Medical Oncology in Bologna, Italy. “In this patient population, Pixuvri offers a treatment option in later lines.”