Enhertu (fam-trastuzumab deruxtecan-nxki) has received FDA approval for HR-positive, HER2-low, HER2-ultralow metastatic breast cancer.

Shares of solid tumor concern Zymeworks Inc. have barely budged since the company obtained its first approval. Click here to read why ZYME stock is a Hold.

Enhertu is a HER2-directed antibody and topoisomerase ... central review based on Response Evaluation Criteria in Solid Tumors v1.1 In the HER2-low population, findings showed treatment with ...

AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...

More common side effects in people receiving Enhertu for breast cancer, NSCLC, or solid tumors include: Mild side effects that may occur from receiving Enhertu may vary depending on the condition ...

Enhertu is already approved for patients with HR+, HER2-low breast cancer after endocrine therapy ... FDA earlier this year for all HER2-positive solid tumours, regardless of their location ...

Pfizer has ended development of a B7-H4-directed antibody-drug conjugate (ADC), triggering a $1 billion impairment charge. | ...

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

The companies’ sBLA was seeking approval for Enhertu to treat unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one ...