MorphoSys AG (NASDAQ:MOR) and Incyte Corporation (NASDAQ:INCY) have announced the European Marketing Authorization Application (MAA) validation for the anti-CD19 antibody tafasitamab.
MorphoSys and Incyte seeking approval of tafasitamab in r/r DLBCL
The MAA is seeking approval of the combination of tafasitamab and lenalidomide and then followed by a tafasitamab monotherapy in the treatment of refractory or relapsed diffuse large B-cell lymphoma patients as well as DLBCL that results for low-grade lymphoma in patients who are not autologous stem cell transplant candidates. With the MAA validated by the EU Medicines Agency, it now means that submission is almost done to finalize the formal review process.
Peter Langmuir, the VP of Incyte, indicated that the MAA validation for tafasimab is a huge milestone for the company in the process of availing tafasitamab for use in eligible DLBCL patients in combination with lenalidomide across Europe. He added that the company has continued to work closely with the medicines agency to advance the review process of the application with the hope of delivering a novel therapy to patients very soon.
On the other hand, MorphoSys chief R&D officer Malte Peters stated that they were delighted to attain such an important milestone of moving the combination of tafasitamab with lenalidomide ton a formal review process in Europe. Peters added that early this year, the FDA accepted the company’s Biologics License Application for Priority Review of tafasitamab.
Incyte to hold marketing authorization of tafasitamab
The application to the EMA submitted by MorphoSys is abed on the L-MIND data that evaluated the combination of tafasitamab with lenalidomide in treating r/r DLBCL patients. Data was supported through the Re-MIND study, which was an observational r/r DLBCL retrospective study. Once the application is approved, Incyte will be the holder of marketing authorization and will also have all commercialization rights for the drug outside the US.
DLBCL is considered the most common non-Hodgkin lymphoma type, and it affects around 40% of adults globally. The disease affects B-cells of the immune system in relapse patients or those that don’t respond.