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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...
Exhibition booth Seattle Genetics - ASCO 2019 | Courtsey: Emila Duaerte / Sunvalley Communication

Enfortumab Vedotin Receives Regular Approval and an Expanded Indication for Locally...

The U.S. Food and Drug Administration (FDA) has granted regular approval for enfortumab vedotin-ejfv (Padcev®; Astellas Pharma and Seagen) while, at the same time,...

Withdrawal of FDA’s Accelerate Approved Therapeutic Agents may harm Patients

The United States Food and Drug Administration’s (FDA) program to accelerate approval of some promising therapeutic agents has recently come under fire due to...
Astellas Pharma. Exhibition booth during the 2019 annual meeting of the American Society of Medical Oncology (ASCO).

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...

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...

FDA Grants Breakthrough Therapy Designation to Enfortumab Vedotin-ejfv in First-Line Advanced...

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma and Seattle Genetics) 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...

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...

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