Tag: HER2

Enhertu Gets Tumor-Agnostic FDA Approval for HER2-Positive Cancers

— About half of patients responded, duration of response as long as 19 months in three trials

April 5, 2024 9:00 am

By Charles Bankhead

The FDA granted tumor-agnostic accelerated approval to trastuzumab deruxtecan (Enhertu) for previously treated unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid cancers.

The action represents the first tumor-agnostic approval for an antibody-drug conjugate targeting HER2-positive tumors. According … Read more

Priority Review Granted for Trastuzumab Deruxtecan; Would Be First Tumor-Agnostic ADC

A tumor-agnostic approval would be a significant development in the advance of antibody-drug conjugates (ADCs), which are designed to deliver a potent, cancer-fighting payload into a tumor while sparing nearby tissues.

January 30, 2024 9:00 am

Clearity’s Perspective: Most drugs are tested and approved to treat cancers based on where in the body the cancer started and the type of tissue from which it developed. Enhertu (Trastuzumab Deruxtecan, T-Dxd), a HER2-targeted antibody drug conjugate (ADC), already … Read more

NCCN Guidelines Update Adds Mirvetuximab Soravtansine Plus Bevacizumab for FRα-Expressing, Platinum-Sensitive Ovarian Cancer

January 19, 2024 9:00 am

Clearity’s Perspective: In the January 17, 2024 update to the National Comprehensive Cancer Network (NCCN) guidelines for ovarian cancer, several new therapies have been added to the list of acceptable regimens for recurrent platinum-resistant ovarian cancer. For example, trastuzumab deruxtecan … Read more