Tag Oncology

EMA validated for review a Type II variation application for PADCEV® with KEYTRUDA® as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.

If approved, PADCEV with KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la Ahsan Arozullah, M.D., M.P.H., Senior Vice President,…

Enhertu has been granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who…

EMA validated for review a Type II variation application for PADCEV® with KEYTRUDA® as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.

Pfizer and Astellas Pharma announced that on January 26 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients…

The European Commission has granted marketing authorisation for Tecentriq® SC, the EU’s first PD-(L)1 cancer immunotherapy for subcutaneous injection. 

The European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union’s first PD-(L)1 cancer immunotherapy for subcutaneous injection.  Roche announced that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union’s first PD-(L)1…