Last Updated on October 14, 2024 by The Health Master
CDSCO approval
AstraZeneca has achieved a significant milestone in the fight against lung cancer. The company has received Central Drugs Standard Control Organization approval (CDSCO approval) to import and distribute Durvalumab, a promising immunotherapy drug, for a new indication.
Durvalumab’s Expanded Role
Durvalumab, previously known for its use in treating advanced lung cancer, has now been approved for earlier intervention in patients with resectable non-small cell lung cancer (NSCLC).
This groundbreaking treatment involves a combination of chemotherapy and Durvalumab before surgery, followed by Durvalumab monotherapy after the procedure.
Targeting Resectable Lung Cancer
This innovative approach is designed to benefit patients with NSCLC who have tumors measuring 4 cm or smaller and/or have positive lymph nodes.
Importantly, this treatment is indicated for patients without known EGFR mutations or ALK rearrangements.
Addressing a Significant Patient Population
Lung cancer remains a formidable health challenge in India, claiming the lives of many each year.
According to the GLOBOCAN 2022 data, lung cancer is the fourth most common cause of cancer-related mortality in the country.
Approximately 15% of NSCLC patients in India have resectable disease, making this new use option a potential game-changer for a substantial number of individuals.
The AEGEAN Trial
The CDSCO approval of Durvalumab for this new indication is based on the promising results of the AEGEAN clinical trial.
This study demonstrated that the Imfinzi-based regimen significantly improved outcomes in patients with resectable lung cancer.
The findings underscore the importance of early diagnosis and use for lung cancer, as patients in earlier stages of the disease have a higher chance of achieving a cure.
In conclusion, AstraZeneca’s Durvalumab has taken a significant step forward in the battle against lung cancer.
The recent CDSCO approval for a new indication offers hope to patients with resectable NSCLC.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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