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Genmab Announces Financial Results for the First Half of 2021

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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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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 ,

Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biol

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09-Apr-2021
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
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
COPENHAGEN, Denmark & BOTHELL, Wash. (BUSINESS WIRE)
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 F ....

New Jersey , United States , Roger Dansey , Marisol Peron , 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 , Chief Executive Officer ,

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
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

New Jersey , United States , Peggy Pinkston , Genmaba Skalvebod Brygge , Tisotumab Vedotintisotumab , Roger Dansey , Marisol Peron , Andrew Carlsen , Semin Thromb Hemost , National Cancer Institute , European Network Of Gynaecological Oncological Trial Groups , European Society Of Medical Oncology Virtual Congress , Genmab Forward Looking Statementsthis Company Announcement , Drug Administration , Gynecologic Oncology Group , Seagen Inc , Exchange Commission , Company Annual Report On Form , European Union , Virtual Congress , European Society For Medical Oncology , Company Announcement , European Society , Medical Oncology Virtual Congress , Priority Review , Biologics License Application ,

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 ,