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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]

Mirvetuximab Soravtansine Demonstrates Overall Survival Benefit in FRα-Positive Platinum-Resistant Ovarian Cancer

Positive top-line data from the Phase 3 confirmatory MIRASOL trial (NCT04209855; GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of mirvetuximab soravtansine-gynx compared to chemotherapy in patients with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy.

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...
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...

Tisotumab vedotin Demonstrates Encouraging Response Rate and a Manageable Safety Profile...

Preliminary clinical data for tisotumab vedotin, also known as HuMax®-TF-ADC from a Genmab-sponsored phase I/II clinical trial (GEN 701) were featured today in an...

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