Image Source: Medical Dialogues
AstraZeneca Pharma India has secured a significant regulatory milestone, receiving approval from the Central Drugs Standard Control Organization (CDSCO) to import and market Osimertinib Tablets (brand name TAGRISSO) in 40 mg and 80 mg doses. This move paves the way for broader access to cutting-edge therapies for Indian patients battling advanced lung cancer.
Key Highlights
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The CDSCO approval allows AstraZeneca to import and distribute Osimertinib for a new indication: as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring specific EGFR mutations (exon 19 deletions or exon 21 L858R substitutions).
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NSCLC is the most prevalent form of lung cancer, and these particular genetic mutations are commonly found in Indian patients, making this approval especially impactful for the country’s cancer care landscape.
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TAGRISSO, already recognized globally as a standard-of-care therapy, will now be available in India for this expanded use, subject to any further statutory clearances.
This regulatory nod follows a series of recent approvals for AstraZeneca’s oncology portfolio in India, including Durvalumab (Imfinzi) for small cell lung cancer, underscoring the company’s commitment to bringing innovative therapies to Indian patients.
AstraZeneca Pharma India’s robust financial performance, with a 44% jump in Q3 FY25 revenues and a surge in net profit, reflects the growing demand for advanced cancer treatments in the country.
The company continues to focus on expanding its oncology offerings, supporting clinical research, and improving access to life-saving medicines across India.
With this latest approval, AstraZeneca Pharma India is set to enhance the standard of care for thousands of lung cancer patients, marking another step forward in the nation’s fight against cancer.
Sources: Business Standard, Moneycontrol, Medical Dialogues, Angel One, India Pharma Outlook
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