Last Updated on March 14, 2025 by The Health Master
Durvalumab
The Central Drugs Standard Control Organisation approval (CDSCO approval) has been granted to AstraZeneca India Ltd. for the import and distribution of the drug, i.e., Durvalumab in India.
This CDSCO approval is an important moment, as Durvalumab is now granted permission for use in patients grappling with limited-stage small cell lung cancer (LS-SCLC).
This permission brings a new hope for the patient suffering with a new and challenging form of cancer.
A New hope for LS-SCLC Patients Post-CRT
Durvalumab stands out as the first approved consolidation therapy for LS-SCLC patients after CRT.
This milestone represents a paradigm shift in the treatment landscape for this aggressive cancer, which accounts for approximately 15% of all lung cancer cases.
Approximately 25% of patients suffer from small cell lung cancer in a year and are diagnosed at an early stage, wanting the urgent requirement of enhanced modality of treatment.
This CDSCO approval directly addresses this critical need, offering a much-needed lifeline to patients.
Critical Healthcare Challenge
In India, lung cancer disease is very challenging, and India is fourth in ranking with respect to the deaths due to cancer, as per GLOBOCAN 2022 data.
Traditionally, treatment for LS-SCLC was confined to platinum-based CRT.
The Indian participants have completed the clinical trial and come out with the finding that it may increase the patient survival rate and reduce the risk of cancer progression when administered post-CRT.
This clinical evidence solidifies Durvalumab’s efficacy and potential to transform patient outcomes.
Expert Insights and the Path Forward
Dr. Hardik Vasnawala, Director of Medical Affairs at AstraZeneca Pharma India Ltd., emphasized the company’s commitment to scientific advancement and enhancing cancer diagnosis.
“We are following the science to enhance our understanding of the complexities associated with cancer and have an equal focus on transforming the way people with cancer are diagnosed.
This new Durvalumab approval is a pivotal step forward in improving outcomes for patients with LS-SCLC in the country and helps address the unmet patient needs,” he stated.
This CDSCO approval underscores the critical importance of early-stage lung cancer diagnosis and treatment, offering a beacon of hope for improved patient outcomes.
This above-mentioned development may focus on early detection and management of lung cancer in India.
Q: What is Durvalumab?
A: Durvalumab is an immunotherapy drug that helps the body’s immune system fight cancer cells.
Q: Who is Durvalumab approved for?
A: Durvalumab is approved by CDSCO for import and distribution in India for the treatment of the patients who is suffering with limited-stage small cell lung cancer (LS-SCLC) in India.
Q: What is the ADRIATIC clinical trial?
A: ADRIATIC is a clinical trial that studied the safety and efficacy of Durvalumab in patients suffering with LS-SCLC after CRT.
Q: What is the importance of this approval in India?
A: This approval provides a new and effective treatment option for patients suffering with in India, providing a urgent and quick medical aid.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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