Tag: Padcev
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...
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 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...
