The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...

The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...

During a Case-Based Roundtable event, Laura Huppert, MD, discussed data and considerations around using T-DXd in breast ...

The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...

Novartis’ Kisqali (ribociclib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat a ...

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...

The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.

Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...

The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...

Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated ...

A phase 3 clinical trial has shown that adding a targeted immunotherapy drug to chemotherapy dramatically improved – almost ...