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Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer | ||
By: GlobeNewswire - 02 Feb 2024 | Back to overview list |
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Media Release
Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. If approved, tisotumab vedotin would be the first ADC granted European Union (EU) marketing authorization for people living with cervical cancer. The MAA is based on data from the global, randomized, Phase 3 innovaTV 301 trial (NCT04697628), in which tisotumab vedotin demonstrated superior overall survival (OS), progression-free survival (PFS) and a confirmed objective response rate (ORR) in patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Data from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer was also included in the MAA. The safety profile of tisotumab vedotin in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information. “The validation of our application is an important milestone supporting our commitment to bringing a new therapeutic option for recurring or metastatic cervical cancer to more patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer, Genmab. “There continues to be a need for therapeutic options for these patients, and we’re dedicated to delivering potential improved outcomes to women diagnosed with this devastating disease.” “Today’s milestone signifies our progress in exploring the availability of tisotumab vedotin for more patients with recurrent or metastatic cervical cancer,” said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. “We remain dedicated to collaborating closely with regulatory authorities, while we navigate the process to potentially deliver a new therapeutic option to people facing this debilitating disease.” About Cervical Cancer About the innovaTV 301 Trial Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint is overall survival. The main secondary outcomes are progression-free survival, confirmed objective response rate, time to response, and duration of response, as assessed by the investigator, as well as safety and quality of life outcomes. The study was conducted by Seagen, recently acquired by Pfizer, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057). For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov. About Tisotumab Vedotin Tisotumab vedotin-tftv (Tivdak®) is approved in the U.S. under the accelerated approval program, and a supplemental Biologics License Application (sBLA) seeking to convert its accelerated approval to a full approval was granted Priority Review by the U.S. Food and Drug Administration (FDA). Use of tisotumab vedotin in recurrent or metastatic cervical cancer is not approved in the EU. About Genmab Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab. About Pfizer Oncology About the Pfizer and Genmab Collaboration Genmab Forward Looking Statements Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; HexaBody®; DuoHexaBody® and HexElect®. Tivdak® is a trademark of Pfizer Inc. Pfizer Disclosure Notice The information contained in this release is as of February 2, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.? This release contains forward-looking information about Pfizer Oncology and TIVDAK® (tisotumab vedotin-tftv), including the MAA pending with the EMA for TIVDAK for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy, potential to convert the accelerated approval of TIVDAK in the U.S. to full approval and potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of TIVDAK; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in particular jurisdictions for TIVDAK; whether and when any applications that may be pending or filed for TIVDAK may be approved by regulatory authorities (including the sBLA seeking to convert the accelerated approval of TIVDAK to full approval in the U.S. and the MAA pending with the EMA, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy), which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether TIVDAK will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of TIVDAK; whether the collaboration between Pfizer and Genmab will be successful; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments.? A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the US Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.? INVESTOR & MEDIA CONTACTS Genmab A/S Contacts: For Investor Relations: Pfizer Contacts: For Investor Relations: i Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394–424. https://doi.org/10.3322/caac.21492. Media Release no. 03 Genmab A/S Attachment |
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