Astrazeneca's Durvalumab Gets CDSCO Approval for the Treatment of Biliary Tract Cancer


eMediNexus    19 February 2023

In a statement issued by AstraZeneca, they revealed that durvalumab has received further indication approval from the Central Drugs Standard Control Organization (CDSCO) for the treatment of biliary tract cancer (BTC) in India. They added that with this historic approval, immunotherapy-based combo treatments are now the only ones available in the nation that significantly increase survival rates.


The approval for the AstraZeneca molecule is based on the findings of TOPAZ-1, a phase-3 global clinical trial with patients recruited from India that evaluated immunotherapy plus chemotherapy as first-line treatment for advanced BTCs, according to Dr. Anil Kukreja, vice president of medical affairs and regulatory at AstraZeneca India.


In the study, the combination of durvalumab with chemotherapy (gemcitabine plus cisplatin) demonstrated improved clinical efficacy, with a 24% decrease in the risk of death compared to chemotherapy alone. The findings of the study suggested that the combined therapy resulted in an increase in the two-year survival rate for twice as many patients in the combination group (23.6%) in comparison to the chemotherapy group (11.5%).


The molecule currently has approval for use in locally advanced or metastatic BTC, applicable for 120 mg/2.4 ml and 500 mg/10 ml solutions for infusion with the indicated additional or expanded indication, subject to receipt of corresponding legislative approvals. 


(Source: http://pharmabiz.com/NewsDetails.aspx?aid=156424&sid=2 )

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