Regulatory

Datopotamab deruxtecan: First TROP2-Directed ADC Approved for First-Line Treatment of mTNBC in Patients Ineligible for Immunotherapy

The U.S. Food and Drug Administration (FDA) has approved additional indications for the Roche PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and VENTANA HER2 Dual ISH DNA Probe Cocktail tests.

Izalontamab Brengitecan Receives U.S. FDA Breakthrough Therapy Designation Advanced EGFR-Mutated Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) has approved belantamab mafodotin (Blenrep®' GSK; see ADC Drugmap), an antibody-drug conjugate (ADC) comprising a humanized BCMA...

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ADCE-D01 for the treatment of soft tissue sarcoma (STS).

AbbVie has submitted a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Pivekimab Sunirine, an investigational...

NICE Approves Enfortumab Vedotin + Pembrolizumab as First-line Treatment for Adults with Metastatic Urothelial Cancer in the UK

The Phase 3 EV-303 is an ongoing clinical trial evaluating enfortumab vedotin (Padcev™; Pfizer and Astellas Pharma), a Nectin-4 directed antibody-drug conjugate (ADC), in combination with pembrolizumab (Keytruda™; Merck & Co), a PD-1 inhibitor, as neoadjuvant and adjuvant treatment (before and after surgery) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy.

Belantamab mafodotin (Blenrep®; GSK), a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker, has been approved in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide

The US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk profile at the proposed dosage of belantamab mafodotin (Blenrep®; GSK) combinations for the treatment of patients diagnosed with multiple myeloma.