The European Medicines Agency has accepted Innate Pharma’s application for a treatment for relapsed or refractory hairy cell leukemia.
Innate Pharma (NASDAQ:IPHA) announced that the European Medicines Agency (EMA) has accepted its application for Lumoxiti (moxetumomab pasudotox-tdfk), a medicine for adult patients with relapsed or refractory hairy cell leukemia who previously received prior systemic therapies.
As quoted in the press release:
“If approved by the EMA, Lumoxiti will be the first treatment available in Europe for relapsed or refractory hairy cell leukemia patients in more than twenty years, potentially changing the standard of care for these patients,” commented Pierre Dodion, MD, Executive Vice President and Chief Medical Officer of Innate Pharma. “We are dedicated in addressing the unmet need in this rare form of cancer that can result in serious and life-threatening conditions, and as such, are hopeful we can bring this important medicine to patients in Europe as soon as possible.”
The EMA filing is based on the final analysis of the pivotal Phase III trial of Lumoxiti, presented at ASH 2019*. These data showed that 36 percent (29/80) of the relapsed or refractory hairy cell leukemia patients achieved durable complete response, defined as a CR with a hematological remission maintained for at least 180 days. The objective response rate (ORR) was at 75 percent. Eighty-one percent of patients with CR experienced eradication of minimal residual disease as reflected by MRD-negative status. In addition, there was a 61 percent probability that patients who achieved a CR would maintain it after five years.