AstraZeneca India Secures CDSCO Nod for Durvalumab in LS-SCLC Treatment

AstraZeneca Pharma India, received a Central Drugs Standard Control Organisation (CDSCO) approval to import for sale and distribution of durvalumab 120 mg/2.4 mL and 500 mg/10 mL solution for infusion. This approval pertains to a new indication - the treatment of patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT).
 
Durvalumab is now the only approved consolidation therapy for LS-SCLC patients post-CRT, marking a pivotal shift in treatment strategy for this aggressive lung cancer subtype, which constitutes approximately 15% of all lung cancer cases. While most SCLC cases are diagnosed at advanced stages, nearly 25% of Indian patients present with LS-SCLC, highlighting an urgent need for enhanced early-stage interventions.
 
GLOBOCAN 2022 data identifies lung cancer as the fourth leading cause of cancer-related mortality in India. Historically, treatment for LS-SCLC was confined to platinum-based CRT. The ADRIATIC clinical trial, which included Indian participants, demonstrated that durvalumab post-CRT significantly improves progression-free and overall survival compared to a placebo, reinforcing its role in optimizing early-stage treatment outcomes.
 
Dr Hardik Vasnawala, director medical affairs, AstraZeneca Pharma India said, ""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 indication approval is a pivotal step forward in improving outcomes for patients with LS-SCLC in the country and helps address the unmet patient needs”.
 
By introducing durvalumab for LS-SCLC in the country, AstraZeneca reaffirms its dedication to improving patient outcomes and advancing oncology healthcare through innovation and strategic partnerships. This development further emphasizes the need to shift lung cancer diagnosis and treatment to earlier stages, where there is greater potential for improved outcomes.

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