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

Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...

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

Depending on the severity of your symptoms, your doctor may recommend that you stop receiving Enhertu and try a different treatment for your cancer. This medication can make lung problems that ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application ...

AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...

Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate. Approval of the new indication was based on data from the phase 3 DESTINY-Breast06 trial (ClinicalTrials.gov Identifier: ...

Enhertu’s label expansion comes on the heels of the FDA’s approval of the partners' Datroway for a related type of breast ...

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

Opens in a new tab or window The FDA expanded the approval of trastuzumab deruxtecan (T-DXd, Enhertu ... breast cancer, non-small cell lung cancer, gastric or gastroesophageal junction cancers ...

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

Study participants with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer ... for Enhertu also includes a Boxed Warning regarding the risk of interstitial lung disease and embryo ...