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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

Combinations with Datopotamab Deruxtecan Show Promising Clinical activity in Treatment of...

Initial results from the TROPION-Lung02 Phase Ib trial demonstrated that that datopotamab deruxtecan (Dato-DXd), a specifically designed TROP2-directed DXd antibody drug conjugate (ADC) being...

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)...

Merck & Co and Seattle Genetics Sign Exclusive Licensing and Co-Development...

Merck & Co and Seattle Genetics have signed an exclusive licensing and co-developing agreement to globally develop and commercialize ladiratuzumab vedotin an investigational antibody-drug...

Potential Accelerated Approval for Enfortumab Vedotin in Combination with Pembrolizumab as...

Updated data from the phase Ib/II multicohort EV-103 trial (NCT03288545; also known as KEYNOTE-869) of enfortumab vedotin* (Padcev™; Seattle Genetics/Astellas Pharma) in combination with...

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 &...

Novel Treatments are a Positive Development for Patients with Metastatic Urothelial...

This week has brought welcome news to bladder cancer patients and their loved ones. Two drugs with great potential for combatting different types of...

Enfortumab Vedotin + Pembrolizumab to be Evaluated in Phase III...

Enfortumab vedotin (also known as AGS-22ME; Seattle Genetics/Astellas), an antibody-drug conjugate (ADC), will be evaluated in a phase III clinical trial in combination with...
General images of ESMO 2019 Congress being held in Barcelona, Spain, September 27 - October 1, 2019. Courtesy European Society for Medical Oncology (ESMO). Used with Permission.

ESMO 2019: Combination of Enfortumab Vedotin + Pembrolizumab Shows High ORR...

Initial results from EV-103, a phase I clinical trial (NCT03288545) of the investigational antibody-drug conjugate enfortumab vedotin (also known as AGS-22ME; Seattle Genetics/Astellas) in...

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