AstraZeneca Pharma India Limited (AZPIL) today 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) programs.
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.
Mr. Gagan Singh Bedi, Managing Director, AstraZeneca Pharma India Limited said, "Lung cancer is the leading cause of cancer related mortality in India. Inspite of therapeutic advances, the overall 5-year survival rate of lung cancer is dismal at <5% 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."
Lung cancer is the leading cause of cancer related mortality world-wide and amongst males in India with 5-years survival rates as dismal as 3.7% in India. 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% of patients. These patients are particularly sensitive to EGFRTKIs, 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.
Nearly 28-54% of EGFRm advanced NSCLC patients, whose disease progresses after treatment with an EGFR TKI, develop resistance due to the T790M resistance mutation. There is also a need for medicines with improved CNS efficacy since approximately 16% patients with EGFRm NSCLC have brain metastases at diagnosis, increasing to approximately half of patients within 3 years of diagnosis.
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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