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Supplemental Biologics License Application for Tisotumab Vedotin Accepted for FDA Priority...

The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for tisotumab vedotin (Tivdak®; Genmab and Pfizer) for the treatment of patients with recurrent or metastatic cervical cancer.

Tisotumab Vedotin Significantly Prolongs Overall Survival in Patients with Recurrent/Metastatic Cervical...

Results today from the Phase 3 innovaTV 301 randomized global trial, which showed treatment with tisotumab vedotin (Tivdak®; Seagen/Genmab)* demonstrated a statistically significant and clinically meaningful 30% reduction in the risk of death in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy, compared with chemotherapy (HR: 0.70, 95% CI: 0.54-0.89, p=0.0038).[1]

Zai Lab to Commercialize and Expand Patient Access to Tisotumab...

Zai Lab, a patient focused, global biopharma company committed to driving the next wave of healthcare innovation confirmed that it had signed an exclusive collaboration and...
Featured Image: Genmab's bioreactor laboratory. Photo Courtesy: 2020 Genmab.

Promising Preliminary Data on Tisotumab Vedotin in Patients with Head and...

Preliminary data from the innovaTV 207 global, open-label, multicenter phase 2 trial of tisotumab vedotin (Tivdak®; Seagen and Genmab) as a monotherapy in patients...
Research associate at Genmab, Cell culturing. Photo courtesy: 2020 Genmab/Tuala Hjarnø and Torkil Stavdal

US FDA Grants Accelerated Approval to Tisotumab Vedotin for Recurrent or Metastatic...

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to tisotumab vedotin-tftv (Tivdak™; Seagen/GenMab; previously known as HuMax®-TF-ADC), a first-in-class and only approved...
Featured Image: Genmab's bioreactor laboratory. Photo Courtesy: 2020 Genmab.

U.S. FDA Accepts Priority Review of Tisotumab Vedotin BLA for Patients...

Each year more than 13,500 women in the United States are diagnosed with invasive cervical cancer and approximately 4,200 will die of the disease....
Research associate at Genmab, Cell culturing. Photo courtesy: 2020 Genmab/Tuala Hjarnø and Torkil Stavdal

Biologics License Application for Tisotumab Vedotin Submitted to the U.S. Food...

Genmab and Seagen have submitted a Biologics Licence Application or BLA to the U.S. Food and Drug Administration (FDA) for tisotumab vedotin. The companies are...

Seagen Presents Broad Portfolio of Innovative Immuno-Oncology Data – Featuring Sugar-Engineered...

During the upcoming 35th annual meeting of the Society for Immunotherapy of Cancer’s (SITC) being held November 9-14, 2020, Seagen (previously known as Seattle...

ESMO 2020: Study Shows Meaningful Clinical Activity with Tisotumab Vedotin ...

Tisotumab vedotin, an investigational agent is being developed by Seattle Genetics and Genmab, shows meaningful clinical activity as monotherapy in patients with previously treated...
Featured Image: Genmab's bioreactor laboratory. Photo Courtesy: 2020 Genmab.

Positive Phase II Trial Results for Tisotumab Vedotin Cervical Cancer

The phase II innovaTV 204 trial, a single-arm clinical trial also known as GCT1015-04 or GOG-3023/ENGOT-cx6 (NCT03438396), evaluating tisotumab vedotin administered every three weeks...

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