Roche announced Monday that it had obtained approval from the US FDA for a companion diagnostic test intended to identify patients with bile duct cancer eligible for a new treatment developed by Jazz Pharmaceuticals.
The pharmaceutical group Roche indicates that the American health agency has granted an extension of authorization of use to its Pathway anti-HER2 (4B5) test as an aid to the evaluation of the HER2 level in these patients, with the objective of allow them to benefit from the administration of this targeted treatment.
Ziihera last week became the first FED-approved treatment for inoperable or metastatic HER2-positive (IHC 3+) bile duct cancer.
According to Roche, this type of cancer represents around 3% of gastrointestinal cancers in the United States, but with a poor diagnosis due to its aggressiveness and its often late diagnosis.
The five-year survival rate averages 19% even when the tumor remains localized, with a rate falling to 3% when the cancer has spread to other parts of the body.
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