FDA approves Monjuvi combo for DLBCL

The US Food and Drug Administration (FDA) has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide 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 (ASCT).

Developed MorphoSys (Nasdaq: MOR), whose shares were up 5.6% at 114.00 euros this morning, in January this year, the Germany company entered into a collaboration and license agreement with USA-based Incyte (Nasdaq: INCY) to further develop and commercialize the anti-CD19 antibody, which brought an upfront payment of $750 million and eligibility for up to $1.1 billion in milestones.

Monjuvi has been cleared for marketing under accelerated approval scheme by the US FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.