Incyte (INCY - Free Report) and partner MorphoSys AG (MOR - Free Report) have announced the validation of the European Marketing Authorization Application (MAA) for pipeline candidate tafasitamab.
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19.
The MAA seeks approval of tafasitamab in combination with Bristol-Myers’ (BMY - Free Report) Revlimid, 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, which are not candidates for autologous stem cell transplantation (ASCT).
The validation allows the European Medicines Agency (EMA) to commence the formal review process of the MAA.
The MAA was submitted by MorphoSys. It was based on data from the L-MIND study evaluating tafasitamab, in combination with Revlimid as a treatment for patients with r/r DLBCL. It is supported by the Re-MIND study, an observational retrospective study in r/r DLBCL.
DLBCL is the most common type of non-Hodgkin lymphoma in adults globally and comprises 40% of all cases.
We remind investors that the FDA accepted MorphoSys' Biologics License Application (BLA) this February and granted Priority Review for tafasitamab, in combination with Revlimid for the treatment of r/r DLBCL. The agency set a Prescription Drug User Fee Act (PDUFA) date of Aug 30, 2020. The FDA also granted the Breakthrough Therapy designation to tafasitamab plus Revlimid for the treatment of r/r DLBCL.
This January, MorphoSys and Incyte entered into a collaboration and licensing agreement to develop and commercialize tafasitamab globally. MorphoSys has exclusive worldwide development and commercialization rights to tafasitamab under a June 2010 collaboration and license agreement with Xencor, Inc. (XNCR - Free Report) .
Upon approval, MorphoSys and Incyte will co-commercialize tafasitamab in the United States, while Incyte has exclusive commercialization rights outside the country.
Shares of the company have gained 12.6% so far this year compared with the industry’s 8.6% increase.
A potential approval will enhance Incyte’s portfolio, which is heavily dependent on Jakafi for growth.
Incyte currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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