Monjuvi Approved to Treat Diffuse Large B-Cell Lymphoma

August 3, 2020 – The U.S. FDA has approved Monjuvi® (tafasitamab-cxix), manufactured by MorphoSys AG and Incyte, for use in combination with lenalidomide to treat adults who have relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL-NOS), including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

DLBCL is the most common type of non-Hodgkin lymphoma in the United States. It is an aggressive cancer most commonly seen in patients over the age of 60, though it can affect patients of any age. The disease has several subtypes, but most often is classified as “not otherwise specified,” meaning it does not meet the requirements to fall into any other type. Approximately one-third of DLBCL patients do not respond to initial treatment or experience a relapse, with approximately 10,000 patients in the U.S. diagnosed with relapsed or refractory DLBCL each year who are not eligible for ASCT.

In a clinical study, Monjuvi in combination with lenalidomide delivered an overall response rate of 55%, with a complete response rate of 37%, a partial response rate of 18%, and a median duration of response of 21.7 months.

Recommended dosing is 12mg/kg of patient’s body weight, administered as an intravenous infusion lasting up to 2.5 hours. Monjuvi is used in combination with lenalidomide 25mg for up to 12 cycles, and then as a monotherapy until disease progression or unacceptable toxicity occur. Each cycle is 28 days long, with dosing occurring on Days 1, 4, 8, 15 and 22 of the first cycle, Days 1, 8, 15 and 22 of both the second and third cycles, and Days 1 and 15 of the fourth cycle and all other cycles thereafter.

Monjuvi has launched at a wholesale acquisition cost (WAC) of $1,200 per vial.