EMA Validates Marketing Authorization Application for Tafasitamab

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody. The validation of the European MAA was announced in a May 20, 2020 press release.

The MAA, submitted by MorphoSys, is seeking the approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT). Now that EMA has validated the MAA it can enter the formal review process.

“EMA’s validation of the MAA for tafasitamab is a critical step on the path to making tafasitamab available for use in combination with lenalidomide in eligible patients with r/r DLBCL in Europe,” said Peter Langmuir, group vice-president, Targeted Therapeutics, Incyte, in the press release. “We will continue to work closely with EMA to progress the review of this application, with the hope of bringing this novel therapy to eligible patients as soon as possible.”

“We are pleased to have achieved this important milestone, which moves tafasitamab in combination with lenalidomide into the formal regulatory review process in the European Union,” added Dr. Malte Peters, chief R&D officer, MorphoSys, in the press release. “Following the US FDA’s acceptance of our Biologics License Application filing for tafasitamab for Priority Review earlier this year, this represents another major step forward. We look forward to continuing to work with the regulatory authorities alongside our partners at Incyte to bring this novel therapeutic option to eligible patients in need.”

Source: Incyte