AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation to import and distribute Durvalumab (Imfinzi) for an additional indication in India. Durvalumab's new indication allows its use in combination with chemotherapy for the treatment of patients with resectable non-small cell lung cancer (NSCLC). This clearance broadens the therapeutic usage of Durvalumab by targeting larger tumors and node-positive patients, making it a valuable option for lung cancer treatment.
AstraZeneca Receives Approval for Expanded Use of Durvalumab in India
Introduction
AstraZeneca Pharma India Limited has secured approval from the Central Drugs Standard Control Organisation (CDSCO) to expand the usage of Durvalumab (Imfinzi) in India. This new approval enables the drug to be used in combination with chemotherapy for the treatment of resectable non-small cell lung cancer (NSCLC).
Background
Lung cancer remains a significant health concern worldwide, with NSCLC being the most common type. Treatment options for NSCLC vary depending on the stage of the disease, and include surgery, chemotherapy, radiotherapy, and targeted therapies.
Durvalumab is an immune checkpoint inhibitor that works by blocking the PD-L1 protein on immune cells, thereby unleashing the immune system's ability to fight cancer cells. It is currently approved in India for the treatment of locally advanced unresectable NSCLC and metastatic urothelial carcinoma.
Expanded Indication
The new CDSCO clearance allows for the use of Durvalumab in combination with chemotherapy for the treatment of patients with resectable NSCLC. This indication targets larger tumors and node-positive patients, who have historically faced a higher risk of recurrence and reduced survival rates.
The approval is supported by data from the Phase III PACIFIC trial, which showed that the combination of Durvalumab and chemotherapy significantly improved event-free survival (EFS) and overall survival (OS) compared to chemotherapy alone in patients with resectable NSCLC.
Clinical Significance
The expanded use of Durvalumab in India offers several clinical benefits:
Top 5 FAQs
1. What is resectable NSCLC?
Resectable NSCLC refers to lung cancer that can be surgically removed. It typically involves smaller tumors without significant lymph node involvement.
2. How is Durvalumab used in resectable NSCLC?
Durvalumab is used in combination with chemotherapy, typically before and after surgery. It helps to enhance the immune response and improve outcomes.
3. What are the benefits of combining Durvalumab with chemotherapy?
The combination of Durvalumab and chemotherapy has been shown to improve EFS, OS, and reduce the risk of recurrence in patients with resectable NSCLC.
4. Are there any side effects associated with Durvalumab?
Common side effects of Durvalumab include fatigue, nausea, decreased appetite, diarrhea, and skin reactions. More serious side effects, such as pneumonitis, hepatitis, and colitis, can occur in a small percentage of patients.
5. What is the future of Durvalumab in lung cancer treatment?
Ongoing research is exploring the use of Durvalumab in combination with other therapies, such as radiation therapy and targeted agents. The aim is to further improve outcomes and personalize treatment strategies for lung cancer patients.
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