 Incyte INCY and MorphoSys MOR have announced that the US Food and Drug Administration FDA has approved Monjuvi tafasitamab-cxix plus lenalidomide for adults with relapsed or refractory diffuse large B-cell lymphoma DLBCL not otherwise specified.This includes DLBCL arising from low grade lymphoma, and patients who are not eligible for autologous stem cell transplant ASCT.DLBCL is the most common type of non-Hodgkin lymphoma in adults, with rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with one third of patients not responding to initial therapy or relapsing. In the US each year approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, was approved under accelerated approval by the FDA based on overall response rate ORR. This means that continued approval may require verification in confirmatory trials.Results from the treatments Phase 2 L-MIND study showed an overall response rate ORR of 55 primary endpoint, including a complete response CR rate of 37 and a partial response rate PR of 18. The median duration of response mDOR was 21.7 months key secondary endpoint.The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.The approval of Monjuvi brings a new treatment option to patients in dire need across the United States, cheered Professor Gilles Salles, lead investigator of the L-MIND study. Todays FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy.Monjuvi is expected to be commercially available in the US shortly, where MorphoSys and Incyte will co-commercialize Monjuvi. Outside the US, Incyte has exclusive commercialization rights.Shares in Incyte are up 13 year-to-date, while MOR has sunk 10. Looking forward, analysts see 7 further upside potential for Incyte with an average analyst price target of 105. The Streets consensus on the stock is a cautiously optimistic Moderate Buy.Tafasitamab looms on the horizon as another key revenue-driver longer term wrote Oppenheimer analyst Jay Olson recently. He has a buy rating on the stock and 121 price target 23 upside potential. We view INCY as well-positioned with cash-generative Jakafi sales and future revenues driven by recent approvals and late-stage assets. Several key catalysts are expected in 2H across the pipeline, among which is the tafasitamab PDUFA in 2L DLBCL the analyst told investors.He believes that INCYs lead marketed product, Jakafi, a JAK-12 inhibitor, has significant potential in myelofibrosis MF and polycythemia vera PV and that the company has a deep and promising pipeline which is currently under-valued. See INCY stock analysis on TipRanks.Related News: GW Pharma Scores New FDA Approval For CBD Drug Epidiolex AstraZeneca To Pay Up To 6B For Daiichi Cancer Drug Deal Moderna Could Charge 50-60 Per Covid-19 Vaccine Course- Report More recent articles from Smarter Analyst: Varian Pops 24 In Pre-Market On 16.4B Buyout Deal; BTIG Sticks To Buy Immunic Spikes 35 In Pre-Market On Positive Multiple Sclerosis Data Sanofi, GSK Nearing EU Supply Deal For 300M Covid-19 Vaccine Doses Apple Snaps Up Canadian Payment Startup Mobeewave For 100M - Report 