Tag: Nectin-4
Priority Review for Supplemental Biologics License Application of Enfortumab Vedotin +...
The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for priority review for enfortumab vedotin-ejfv (Padcev® ; Astellas/Seagen with pembrolizumab (Keytryuda® ( Merck & Co; Merck Sharp & Dohme/MSD) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.
First Patient Dosed in Phase 1 Study for BAT8007, an Antibody-Drug...
Dosing has begun in a Phase 1 clinical study evaluating BAT8007, an antibody-drug conjugate (ADC) that targets Nectin-4 being developed by Guangzhou, China-based Bio-Thera...
Corbus Expands Oncology Pipeline with Clinical Stage Nectin-4 Targeting ADC
Corbus Pharmaceuticals, a precision oncology company, today announced that it has entered into an exclusive licensing agreement with CSPC Megalith Biopharmaceutical, a subsidiary of...
Combination of Enfortumab Vedotin with Pembrolizumab Shows Positive Topline Results as...
Cisplatin-based combination chemotherapy has been widely accepted as the first-line treatment option for cisplatin-eligible patients diagnosed with locally advanced or metastatic urothelial cancer (mUC)...
Astellas and Seagen Submit sBLA for Enfortumab Vedotin in Locally Advanced...
Astellas Pharma and Seagen have confirmed that the companies have completed the submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food...
Study Meets Primary Endpoint: Enfortumab Vedotin Significantly Improves Overall Survival in...
A phase III trial of enfortumab vedotin (enfortumab vedotin-ejfv; Padcev®; Seattle Genetics/Astellas) met its primary endpoint of overall survival (OS) compared to chemotherapy.
Globally, approximately...
Updated Results from Trial Shows Enfortumab Vedotin + Pembrolizumab to Shrink...
Updated findings from EV-103, a phase Ib/II clinical trials of enfortumab vedotin* (Padcev™; Astellas Pharma/Seattle Genetics) in combination with pembrolizumab (Keytruda®; Merck Sharp &...
Accelerated Approval for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial...
The U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma / Seattle Genetics)* for the treatment of adult...
ESMO 2019: Seattle Genetics to Present Initial Data from a Phase...
Less than a week before the start of the annual meeting of the European Society for Medical Oncology (ESMO), to be held September 27...
Enfortumab Vedotin Produces High Tumor Response in Metastatic Urothelial Cancer
Enfortumab vedotin (also known as ASG-22CE), an investigational antibody-drug conjugates being developed by Seattle Genetics in collaboration with Astellas Pharma, showed a positive, high...