EMA validates tafasitamab regulatory submission

US biotech Incyte (Nasdaq: INCY) closed up 3.6% at $98.32 yesterday, after announcing, along with partner German drugmaker MorphoSys (FSE: MOR), that the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody, had been validated.

The application seeks approval of tafasitamab in combination with lenalidomide (Bristol-Myers Squibb’s [NYSE} BMY]), followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT).

The validation of the MAA by the European Medicines Agency confirms that the submission is ready to enter the formal review process. A US marketing application is currently under Food and Drug Administration review, with an action date of August 30. A potential approval will enhance Incyte’s portfolio, which is heavily dependent on Jakafi (ruxolitinib) for growth, noted Zacks Equity Research.