AstraZeneca Pharma India has secured approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute durvalumab (Imfinzi) for an expanded indication in India. This approval allows for the use of durvalumab in combination with chemotherapy as a neoadjuvant treatment, followed by durvalumab monotherapy post-surgery, for patients with resectable non-small cell lung cancer (NSCLC). This regulatory decision broadens the therapeutic application of durvalumab, offering a new treatment option for a specific subset of NSCLC patients.
The approved indication targets patients with resectable NSCLC, specifically those with tumors 4 cm or larger and/or node-positive cases, who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. The treatment regimen involves administering durvalumab in conjunction with chemotherapy before surgery (neoadjuvant treatment), followed by durvalumab alone after the surgical resection.
According to a company statement, this approval is contingent upon receiving related statutory approvals. Lung cancer remains a significant health concern in India. GLOBOCAN 2022 data indicates that lung cancer is the fourth most common cause of cancer-related mortality in the country. Approximately 15% of NSCLC patients in India present with resectable disease, highlighting the potential impact of this expanded treatment option.
Clinical Context and Significance
This approval addresses a critical need in the treatment landscape for resectable NSCLC. The neoadjuvant approach, combining chemotherapy with durvalumab, aims to reduce tumor size and eradicate micrometastatic disease before surgery, potentially improving long-term outcomes. Post-operative durvalumab monotherapy then consolidates the treatment effect, targeting any remaining cancer cells.
Durvalumab: Mechanism of Action
Durvalumab is a human monoclonal antibody that binds to programmed cell death ligand-1 (PD-L1), blocking its interaction with PD-1 and CD80. By blocking PD-L1, durvalumab unleashes the T cells, allowing them to recognize and kill cancer cells. This mechanism of action harnesses the body's own immune system to fight cancer.
