Roche: companion diagnostic test approved in US
(CercleFinance.com) - Roche announced Monday that it has received approval from the US FDA for a companion diagnostic test designed to identify biliary tract cancer patients eligible for a new treatment developed by Jazz Pharmaceuticals.
The Roche pharmaceutical group reports that the US health agency has granted an extension of use to its Pathway anti-HER2 (4B5) test as an aid in assessing HER2 levels in these patients, with the aim of enabling them to benefit from the administration of this targeted treatment.
Last week, Ziihera became the first treatment for inoperable or metastatic HER2-positive (IHC 3+) biliary tract cancer to be approved by the FED.
According to Roche, this type of cancer accounts for around 3% of gastrointestinal cancers in the USA, but with a dismal diagnosis due to its aggressiveness and often late diagnosis.
The five-year survival rate averages 19% even when the tumor remains localized, falling to 3% when the cancer has spread to other parts of the body.
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The Roche pharmaceutical group reports that the US health agency has granted an extension of use to its Pathway anti-HER2 (4B5) test as an aid in assessing HER2 levels in these patients, with the aim of enabling them to benefit from the administration of this targeted treatment.
Last week, Ziihera became the first treatment for inoperable or metastatic HER2-positive (IHC 3+) biliary tract cancer to be approved by the FED.
According to Roche, this type of cancer accounts for around 3% of gastrointestinal cancers in the USA, but with a dismal diagnosis due to its aggressiveness and often late diagnosis.
The five-year survival rate averages 19% even when the tumor remains localized, falling to 3% when the cancer has spread to other parts of the body.
Copyright (c) 2024 CercleFinance.com. All rights reserved.