Tag: enfortumab vedotin
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.
Enfortumab Vedotin + Pembrolizumab Significantly Extends OS and PFS in...
Results from the Phase 3 EV-302/KEYNOTE-A39 clinical trial for enfortumab vedotin (Padcev®; Astellas/Seagen) in combination with pembrolizumab (Keytruda®; Merck & Co/MSD) versus chemotherapy, presented at the European Society for Medical Oncology (ESMO) Congress 2023
AACR 2023: Preclinical Data Highlights Stable and Efficacious Low Drug-Load ADCs
Two poster presentations at the American Association for Cancer Research (AACR) 2023 Annual Meeting, being held April 14-19, 2023 at the Orange County Convention Center in Orlando, Florida, highlight late-breaking preclinical data from studies with an anti-Nectin-4 ADC and anti-HER2 ADC.
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...
Pfizer to Acquire Seagen for US $ 43 Billion
Pfizer and Seagen have entered into a definitive merger agreement under which Pfizer will acquire Seagen for US $229 in cash per Seagen share...
World ADC 2023 London – What to Expect
With renewed focus and commitment in creating a platform for innovative scientific insights and transformative experiences, 13th World ADC in London, held March 13...
Stable, Site-Specific ADC Conjugation with SMARTag® Technology and Innovative Linker
Antibody-drug conjugates have achieved commercial success over the last 10 years with 15 therapies launched globally to date, including 11 with U.S. FDA approval, and two biosimilars. With their ability to direct highly potent cytotoxic payloads selectively to target cells, ADCs offer the prospect of more precise treatments and a reduction in off-target effects.
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)...
European Medicines Agency Recommends Approval of Enfortumab Vedotin Monotherapy for Locally...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previously adopted positive opinion, recommending approval...
Japan Approves Enfortumab Vedotin for the Treatment of Advanced Urothelial Cancer
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved enfortumab vedotin (Padcev®; Astellas Pharma and Seagen) for the treatment of radically unresectable urothelial...