MorphoSys receives FDA approval for Monjuvi
MorphoSys AG (MOR) announced that the FDA has approved the use of Monjuvi in conjunction with lenalidomide, for treating adult patients suffering from relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL concerning low grade lymphoma, and who do not qualify for autologous stem cell transplant. The company is collaborating with Incyte (INCY) for developing this drug candidate.
Monjuvi is the first FDA approval for a second-line treatment for adult patients with the condition. Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys said “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.” Monjuvi is a humanized Fc-modified cytolytic CD19 and it works by targeting monoclonal antibody.
The approval granted by the FDA is based on the data collated from the MorphoSys-sponsored Phase 2 L-MIND study. It was an open label, multicenter, single arm study. The data from the trial demonstrated the overall response rate at 55 percent, thus meeting the primary endpoint of the trial. The complete response rate was recorded at 37 percent while a partial response rate of 18 percent. further, the median duration of response mDOR was found at 21.7 months, forming a key secondary endpoint.
The L-MIND trial involved patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy. The primary endpoint of the trial was overall response rate while secondary endpoints included progression-free survival, overall survival and duration of response.
The drug candidate was given Fast Track, Priority Review and Breakthrough Therapy tags by the FDA. The Breakthrough Therapy designation provides for expedited development and review of
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