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Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First...

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First and Only ADC + PD-1 Combination to Treat Advanced Bladder Cancer

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

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...
Astellas Pharma. Exhibition booth during the 2019 annual meeting of the American Society of Medical Oncology (ASCO).

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...

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