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Incyte Announces Health Canada Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Incyte Announces Health Canada Approval of Minjuvi® (tafasitamab) in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab

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MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab
January 12, 2021 GMT
PLANEGG/MUNICH, GERMANY and MONTREAL, QC / ACCESSWIRE / January 12, 2021 / MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that Health Canada has accepted the New Drug Submission (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 (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT). ....

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MorphoSys AG: MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab

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PLANEGG/MUNICH, GERMANY and MONTREAL, QC / ACCESSWIRE / January 12, 2021 / MorphoSys AG (FSE:MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that Health Canada has accepted the New Drug Submission (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 (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).
With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL, said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. We intend to ....

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