CDSCO approves Durvalumab
20 Feb 2023 • The Central Drugs Standard Control Organization (CDSCO) has approved Durvalumab in India, which is used to treat biliary tract cancer. The results of TOPAZ-1, a phase-3 international clinical study that included patients from India as well, which assessed immunotherapy plus chemotherapy as the first line treatment for advanced BTCs, formed the basis for the approval of this drug. Every year, India reports about 30,000 new cases of BTCs, 90% of which are detected at an advanced stage. In fact, statistics indicate that the northern region of India has a high incidence of gall bladder cancer. In fact, statistics indicate that the northern region of India has a high incidence of gall bladder cancer. As early-stage BTC frequently presents without obvious symptoms, the majority of new cases of BTC are therefore detected at an advanced stage, when treatment choices are few and the prognosis is poor. Chemotherapy was the only option for treatment for the past ten years, and the survival statistics were discovered to be appalling. This historic approval becomes the only immunotherapy-based combination treatment available in India that significantly increases survival rates.
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