{"id":15581,"date":"2021-01-21T13:45:35","date_gmt":"2021-01-21T12:45:35","guid":{"rendered":"https:\/\/www.izb-online.de\/morphosys-und-incyte-geben-die-annahme-des-zulassungsantrags-fuer-tafasitamab-durch-health-canada-bekannt\/"},"modified":"2021-01-22T11:19:25","modified_gmt":"2021-01-22T10:19:25","slug":"morphosys-und-incyte-geben-die-annahme-des-zulassungsantrags-fuer-tafasitamab-durch-health-canada-bekannt","status":"publish","type":"post","link":"https:\/\/www.izb-online.de\/en\/morphosys-und-incyte-geben-die-annahme-des-zulassungsantrags-fuer-tafasitamab-durch-health-canada-bekannt\/","title":{"rendered":"MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab"},"content":{"rendered":"

[vc_row el_class=”gco-magazine-container”][vc_column el_class=”bildspalte”][vc_row_inner][vc_column_inner offset=”vc_col-lg-12 vc_col-md-12″][vc_column_text el_class=”gco-magazine–title”]<\/p>\n

MorphoSys and Incyte Announce Acceptance by Health Canada of the New Drug Submission for Tafasitamab<\/h1>\n

[\/vc_column_text][vc_column_text el_class=”gco-magazine–post-date”]January 2021[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner][vc_column_inner][vc_single_image image=”15596″ img_size=”full”][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine–quote” css=”.vc_custom_1611310764469{margin-top: 33px !important;}”][vc_column_inner][vc_column_text]<\/p>\n

\u201cThis important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL.\u201d<\/h6>\n

Dr. Nuwan Kurukulasuriya
\nSenior Vice President, Global Medical Affairs bei MorphoSys<\/p>\n

[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine-container–copy” css=”.vc_custom_1591795890737{margin-top: 21px !important;}”][vc_column_inner][vc_column_text]MorphoSys AG\u00a0 and Incyte announced in January 2021 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).<\/p>\n

\u201cWith 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,\u201d said Jos\u00e9e Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. \u201cWe intend to work closely with Health Canada as we seek to bring this innovative targeted therapeutic option to the clinical community and to appropriate patients for whom few treatment options exist.\u201d<\/p>\n

\u201cThis important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL,\u201d said Nuwan Kurukulasuriya, Ph.D., Senior Vice President Global Medical Affairs, MorphoSys.<\/p>\n

The NDS, submitted by Incyte, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL.<\/p>\n

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. This NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.[\/vc_column_text][vc_column_text css=”.vc_custom_1583761043671{background-color: #1e73be !important;}” el_class=”redaktionell”][\/vc_column_text][\/vc_column_inner][\/vc_row_inner]\n\n

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\n MorphoSys AG <\/div>\n\n