The researchers found that imlunestrant prolonged progression-free survival (PFS) when compared to standard care in patients with ESR1 mutations, but there was no PFS benefit observed in the overall ...
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
The Phase III trial saw a clinically meaningful benefit in overall survival with a combination of Itovebi alongside Ibrance ...
Enhertu first secured approval in 2019 for patients with high levels of HER2, a protein that promotes cancer cell growth. In ...
The FDA has approved an expanded label for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test, which ...
Roche has secured a new FDA approval for its first companion diagnostic test aimed at identifying breast cancer patients with ...
The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...
Among patients with advanced PIK3CA-mutated, HR-positive/HER2-negative breast cancer, Itovebi-based treatment generated ...
The findings suggest that reconsideration of current clinical guidelines, which support MRI only for symptomatic brain ...
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...
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