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Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer
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Seagen Inc.: Seagen and Genmab Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

(1)
- FDA Action Date is October 10, 2021 -
- BLA Submission Supported by Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 -
Seagen Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of October 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis a ....

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Genmab A/S: Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer

(1)
FDA action date is Oct 10, 2021
BLA submission supported by positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020
Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of Oct 10, 2021. Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell-surface protein expressed on multiple solid tumors including cervical cancer, and is associated with tumor growth, angiogenesis, metastasis and poor prognosis. ....

New Jersey , United States , Roger Dansey , Marisol Peron , Peggy Pinkston , Tisotumab Vedotin , Semin Thromb Hemost , Andrew Carlsen , National Cancer Institute , European Network Of Gynaecological Oncological Trial Groups , European Society Of Medical Oncology Virtual Congress , Drug Administration , Gynecologic Oncology Group , Seagen Inc , Exchange Commission , Company Annual Report On Form , European Union , Virtual Congress , European Society For Medical Oncology , Global Investor Relations Communications , Company Announcement , European Society , Medical Oncology Virtual Congress , Priority Review , Biologics License Application , Prescription Drug User Fee Act ,

Seagen and Genmab Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer

Published: Feb 10, 2021

- Submission Based on Positive Pivotal innovaTV 204 Trial Results Presented at the European Society of Medical Oncology Virtual Congress 2020 -

BOTHELL, Wash. & COPENHAGEN, Denmark (BUSINESS WIRE) Seagen, Inc. (Nasdaq: SGEN) and Genmab A/S (Nasdaq: GMAB) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for tisotumab vedotin. This BLA requests FDA approval of tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The submission is based on the results of the innovaTV 204 pivotal phase 2 single-arm clinical trial evaluating tisotumab vedotin as monotherapy in this setting. The topline results from the phase 2 study were announced in June 2020 and data were presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. Tisot ....

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Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer

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11-Feb-2021
Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
Company Announcement
Submission based on positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020
COPENHAGEN, Denmark and
BOTHELL, Wash.; Feb 10, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval ....

New Jersey , United States , Tisotumab Vedotin Biologics , Roger Dansey , Marisol Peron , Peggy Pinkston , Tisotumab Vedotin , Semin Thromb Hemost , Andrew Carlsen , National Cancer Institute , European Network Of Gynaecological Oncological Trial Groups , European Society Of Medical Oncology Virtual Congress , Drug Administration , Gynecologic Oncology Group , Seagen Inc , Exchange Commission , European Union , Company Current Report On Form , Virtual Congress , Company Quarterly Report On Form , European Society For Medical Oncology , Global Investor Relations Communications , Company Announcement , Metastatic Cervical , European Society , Medical Oncology Virtual Congress ,