However, this approval is subject to a condition that the firm should submit the Phase IV clinical trial protocol within 3 months of importing and marketing permission granted.
This came after the drug major AstraZeneca presented the current status of the ongoing clinical trial of Trastuzumab Deruxtecan Powder for Concentrate Solution for Infusion 100mg for import and marketing in India with local Phase III clinical trial waiver.
Trastuzumab Deruxtecan Powder for Concentrate Solution for Infusion 100mg is indicated for treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2- based regimens .
The committee noted that the drug is approved in Japan, US, EU, UK, Israel, Canada, Switzerland, Australia, Singapore, Brazil, Taiwan, Hongkong, UAE, and South Korea.
The committee further highlighted that the drug is indicated for the treatment of life-threatening diseases and there is an unmet medical need in the country.
Trastuzumab deruxtecan is an antibody used to treat certain types of unresectable or metastatic HER-2-positive breast cancer. Trastuzumab deruxtecan is used to treat adults with certain types of HER2-positive or HER2-low breast cancer, HER2-positive stomach cancer or gastroesophageal junction cancer, or non-small cell lung cancer that has a certain mutation in the HER2 gene.
Trastuzumab deruxtecan binds to HER2 on tumour cells, T-DXd undergoes internalization and intracellular linker cleavage by lysosomal enzymes. Upon release, the membrane-permeable DXd enters the nucleus and causes DNA damage and apoptotic cell death.
At the recent SEC meeting for Oncology and Hematology held on 23rd of February 2023, the expert panel reviewed the current status of the ongoing clinical trial of Trastuzumab Deruxtecan Powder for Concentrate for Solution for Infusion 100mg for import and marketing in India which was presented by the drug major AstraZeneca.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with the waiver of Phase III clinical trial in the country with the condition that the firm should conduct a Phase IV trial in a minimum of 150 subjects.
Accordingly, the committee directed the firm to submit the Phase IV clinical trial protocol within 3 months of importing and marketing permission granted.
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