Becomes only approved ‘immuno-oncology’ (IO) therapy across limited and extensive stage SCLC in India
Bangalore, March 7, 2025: AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company, 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. 1
GLOBOCAN 2022 data identifies lung cancer as the fourth leading cause of cancer-related mortality in India.2 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. 3
Dr. Hardik Vasnawala, Director Medical Affairs, AstraZeneca Pharma India Limited 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.
About AstraZeneca Pharma India Ltd
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory and Rare Disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Established in 1979, AstraZeneca Pharma India Limited is headquartered at Bengaluru, Karnataka in India and has a workforce of over 600 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization. For more information, please visit our website: https://www.astrazeneca.in/ or follow us on LinkedIn: AstraZeneca India.
References:
1. Iyer, Hariharan; Ghosh, Tamoghna; Agarwal, Harsh; Garg, Avneet; Pandey, Rambha; Jain, Deepali; Tiwari, Pawan; Mittal, Saurabh; Hadda, Vijay; Madan, Karan; Guleria, Randeep; Mohan, Anant. Clinical profile of small-cell lung cancer in North India: A 12-year analysis from a tertiary care center. Lung India 39(6):p 495-501, Nov–Dec 2022.
2. Ferlay J, Ervik M, Lam F, Laversanne M, Colombet M, Mery L, Piñeros M, Znaor A, Soerjomataram I, Bray F (2024). Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today, accessed 3/3/2025
3. Cheng Y, Spigel DR, Cho BC, Laktionov KK, Fang J, Chen Y, Zenke Y, Lee KH, Wang Q, Navarro A, Bernabe R, Buchmeier EL, Chang JW, Shiraishi Y, Goksu SS, Badzio A, Shi A, Daniel DB, Hoa NTT, Zemanova M, Mann H, Gowda H, Jiang H, Senan S; ADRIATIC Investigators. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med. 2024 Oct 10;391(14):1313-1327.