MorphoSys AG said it will seek EU approval of its experimental cancer therapy tafasitamab in combination with Celgene Corp.'s Revlimid in patients whose diffuse large B cell lymphoma has relapsed or not responded to treatment.
The German biotechnology company submitted a letter of intent to the European Medicines Agency in early July and plans to complete the submission of its marketing authorization application by the middle of 2020. The earliest timeframe for EU approval would be in 2021, MorphoSys said.
The regulatory submission is based on the results of the phase 2 L-MIND study of tafasitamab, also known as MOR208, used with Revlimid, also known as lenalidomide. The study is a single-arm, open-label trial of the combination in patients who are not able to receive high-dose chemotherapy or autologous stem cell transplantation.
L-MIND is a single-arm, open-label phase 2 study investigating the antibody tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma who are not eligible for either high-dose chemotherapy or a transplant of their own stem cells.
"The preceding constructive interaction with the European regulatory authorities has given us the confidence to pursue an MAA submission for approval in Europe based on L-MIND," Malte Peters, chief development officer at MorphoSys, said in an Aug. 6 press release.
MorphoSys plans to submit a biologics license application to the U.S. Food and Drug Administration by the end of 2019, Peters said.