Roche is the recipient of the new approval, getting the go-ahead from the US regulator for its PATHWAY HER2 (4B5) test to ...
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
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 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: ...
Imfinzi recommended for approval in European Union for the treat of adults with limited-stage small cell lung cancer ...
Q3 2024 Management View Revenue for Q3 FY2024 increased 16.6% year-on-year to ¥1,367.6 billion, driven by growth in oncology and international markets. Core operating profit rose 33% to ¥229 billion.
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 ...