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AstraZeneca receives marketing permission for Osimertinib to treat non-small cell lung cancer in India

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Osimertinib (TagrissoTM) will be used as 1st line treatment for NSCLC offering potential new standard of care

AstraZeneca Pharma India (AZPIL) announced that it has received Import & Market permission – additional indication for osimertinib (TagrissoTM) Tablet 40 mg and 80 mg, as 1st line treatment for EGFRm advanced Non-Small Cell Lung Cancer (NSCLC) by the Drug Controller General of India (DCGI). The receipt of this permission paves way for the launch of osimertinib in India for 1st line treatment.

Osimertinib is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations.

Osimertinib is already approved and available for the treatment of patients with metastatic EGFR T790M mutation‐positive NSCLC, as detected by an appropriate test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. AstraZeneca has been pioneering access to T790M mutation testing in India through interventions in infrastructure, scientific knowledge dissemination to medical and pathological experts and standardization of test quality through independent External Quality Assurance (EQA) programmes.

In 2017, osimertinib was granted ‘Breakthrough Therapy’ status and ‘Priority Review’ designations by the US FDA in 1st line treatment setting. Osimertinib is a patented product of AstraZeneca group.

Gagan Singh Bedi, Managing Director, AstraZeneca Pharma India said, “Lung cancer is the leading cause of cancer related mortality in India. Inspite of therapeutic advances, the overall five year survival rate of lung cancer is dismal at <5 per cent in India. Tagrisso’s approval in first line treatment is an exciting advance in bringing a potential new standard of care to patients with EGFRm advanced NSCLC in India. Clinical data suggests early and sustained benefit with Osimertinib in first line treatment that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains in the treatment of lung cancer.”

Various studies have suggested that nearly all the lung cancer cases are non-small cell lung cancers (NSCLC), of which EGFR-TKI sensitising mutations are observed in 23 – 50 per cent of patients. These patients are particularly sensitive to EGFR-TKIs, which block the cell-signaling pathways that drive the growth of tumour cells. However, tumours almost always develop resistance to EGFR-TKI treatment, leading to disease progression.

Osimertinib (Tagrisso) is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising (exon 19 deletions or exon 21 (L858R) substitutions mutations) and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.

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