FDA Approves Tafasitamab, Lenalidomide Combination to Treat Relapsed/Refractory DLBCL

August 3, 2020

The FDA has approved tafasitamab-cxix in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

The FDA approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant, according to MorphoSys AG and Incyte.

Of note, this is the first fDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL.

“The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States,” Hervé Hoppenot, chief executive officer of Incyte, said in a press release issued by Incyte. “At Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community.”

The approval was based on results from the open-label, multicenter, single-arm phase 2 L-MIND study, designed to evaluate tafasitamab-cxix in combination with lenalidomide in adult patients with relapsed or refractory DLBCL.

The overall response rate was 55%, including 37% of patients with a complete response 18% with a partial response.

“We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials,” Jean-Paul Kress, MD, chief executive officer, at MorphoSys, stated in the release. “This approval marks an important step in MorphoSys’ transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases.”

Reference:

Incyte. FDA Approves Monjuvi (tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL). Published July 31, 2020. Accessed July 31, 2020. https://investor.incyte.com/news-releases/news-release-details/fda-approves-monjuvir-tafasitamab-cxix-combination-lenalidomide.