MorphoSys And Incyte : Health Canada Accepts NDS For Anti-CD19 Antibody Tafasitamab

MorphoSys AG (MOR) and Incyte (INCY) said that Health Canada has accepted the New Drug Submission or NDS for tafasitamab, an anti-CD19 antibody.

The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma or DLBCL, including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant or ASCT.

Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada.

MorphoSys noted that the NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

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