Incyte (Nasdaq: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Minjuvi® (tafasitamab)
- Minjuvi is an important new therapeutic option for eligible patients with DLBCL in Canada, addressing an urgent unmet medical need - This marks the first marketing authorization by Health Canada for Incyte since establishing Incyte Biosciences Canada in April 2020 MONTREAL, Aug. 24, 2021 /CNW/ -Incyte Corporation (Nasdaq: INCY) today announced that Health Canada has granted a Notice of Compliance with conditions for Minjuvi® (tafasitamab), a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT). “The data from L-MIND demonstrated that eligible patients treated with tafasitamab and lenalidomide had a high likelihood of benefit, which was durable in many cases,” said Dr. Laurie Sehn, Clinical Professor with BC Cancer Centre for Lymphoid Cancer and The University of British Columbia. “It is encouraging to see new treatments become available for patients with relapsed or refractory DLBCL, especially given the historical lack of options for them.” “The approval of Minjuvi is the first marketing authorization for Incyte in Canada and brings an innovative targeted therapeutic option to the Canadian clinical community to treat their patients with relapsed or refractory DLBCL,” said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. “DLBCL is the most common form of non-Hodgkin lymphoma in adults, and Incyte is committed to working to provide access to Minjuvi for the patients in Canada who need it most.” The conditional approval is based on data from the L-MIND study, an open label, multicentre single arm study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for ASCT, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. Removal of the conditions from the Notice of Compliance is contingent upon verification and description of clinical benefit in a confirmatory trial(s). The results from L-MIND showed an overall response rate (ORR) of 53.5% (primary endpoint), including a complete response (CR) rate of 35.2% and a partial response rate (PR) of 18.3%, as assessed by an independent review committee. The median duration of response (mDOR) was 34.6 months (secondary endpoint). Adverse events (AEs) reported included infusion-related reactions, serious or severe myelosuppression, including neutropenia, thrombocytopenia, anemia, infections and tumour lysis syndrome. Incyte and MorphoSys share global development rights to tafasitamab; Incyte has exclusive commercialization rights to tafasitamab outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S. and is marketed by Incyte under the brand name Minjuvi® in Canada. About Diffuse Large B-cell Lymphoma (DLBCL) About L-MIND For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085. About RE-MIND For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328. About Minjuvi® (tafasitamab) In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. The safety and efficacy of tafasitimab in other B-cell malignancies has not been established. Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the United States and marketed by Incyte under the brand name Minjuvi® in Canada. XmAb® is a registered trademark of Xencor, Inc. About Incyte To learn more about Incyte Biosciences Canada, visit https://incytebiosciences.ca. Forward Looking Statements These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the FDA; the Company’s dependence on its relationships with its collaboration partners; the efficacy or safety of the Company’s products and the products of the Company’s collaboration partners; the acceptance of the Company’s products and the products of the Company’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report for the year ended December 31, 2020, and the quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
SOURCE Incyte Biosciences Canada | ||||||||||||
Company Codes: NASDAQ-NMS:INCY |