The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
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FDA expands Enhertu approval to include HER2-ultralow breast cancer patientsEnhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
The international consulting firm Clarivate makes its bet among the novelties ready for the medicine cabinet this year: three ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.
Just 11 days after AstraZeneca and Daiichi Sankyo gained FDA approval | The FDA has cleared AstraZeneca and Daiichi Sankyo's ...
The U.S. Food and Drug Administration has approved Datroway (datopotamab deruxtecan-dlnk) for adult patients with ...
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
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: ...
The antibody drug conjugate was approved for patients with unresectable or metastatic HER2-low or -ultralow breast cancer ...
The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU ...
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