AstraZeneca Gets Approval For Import & Marketing Of Lung Cancer Drug In India

AstraZeneca Pharma India Limited announced a regulatory milestone with the receipt of approval from the CDSCO, Government of India, to import and market Osimertinib tablets (TAGRISSO) 40 mg and 80 mg for an expanded indication in India.

Expanded Indication for TAGRISSO

The CDSCO has permitted the use of TAGRISSO as monotherapy for patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, and whose disease has not progressed following platinum-based chemoradiation therapy.

This additional indication significantly strengthens TAGRISSO’s presence in the Indian oncology market by targeting a critical unmet need in NSCLC management, especially in patients where surgical resection is not an option.

Regulatory Pathway and Commercial Strategy

This is in line with AstraZeneca’s strategic plan to strengthen its oncology presence in emerging markets such as India. The company plans to use its broad hospital network and medical visitations to help promote the new indication of TAGRISSO to the commercial market.

About TAGRISSO

TAGRISSO (Osimertinib) is a third-generation EGFR-TKI that selectively inhibits both EGFR sensitizing and T790M resistance mutations. It has played a critical role in the global treatment of lung cancer.  The expanding label of the product will further reinforce AstraZeneca’s oncology portfolio in India.

Forward Outlook

The company is expected to leverage its established hospital network and medical outreach to support the commercial rollout of TAGRISSO for this newly approved indication.

About AstraZeneca Pharma

AstraZeneca Pharma India Ltd., a subsidiary of the global biopharmaceutical leader AstraZeneca Plc, focuses on the therapeutic areas of oncology, cardiovascular, renal, metabolism, and respiratory diseases. It has a legacy of over four decades in India and continues to invest in science-led innovation.

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REF: https://nsearchives.nseindia.com/corporate/ASTRAZEN_29052025112203_Intimation_to_Stock_Exchanges_Tagrisso_Laura.pdf