AstraZeneca receives marketing permission from Drug Controller General of India for Osimertinib

Sanjay Krishna | Myequity news | Date : 09-08-2018 14:00:00 IST

AstraZeneca Pharma India Limited (AZPIL) today announced that it has received Import and 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 makes 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 ormetastatic non-small cell lung cancer whose tumours have epidermal growth factorreceptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations.

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

osimertinib was granted ‘Breakthrough Therapy’ status and ‘Priority Review’designations by the US FDA in 1st line treatment setting in 2017.AstraZeneca group has osimertinib as its patented product.

Mr. Gagan Singh Bedi, Managing Director,AstraZeneca Pharma India Limited said, “Lung canceris 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 less than 5% in India. Tagrisso’s approval in first line treatment isan exciting advance in bringing a potential new standard of care to patients with EGFRm advancedNSCLC in India. Clinical data suggests early and sustained benefit with Osimertinib in first linetreatment that has the potential to significantly impact long-term patient outcomes and help address theconsiderable unmet need that remains in the treatment of lung cancer.”

About Osimertinib (TagrissoTM) :

Osimertinib is a third-generation, irreversible, oral EGFR-TKI that potently and selectively inhibits both EGFRm and EGFR T790M resistance mutations, spares wild-type EGFR, and has demonstrated clinical activity in CNS metastases. TagrissoTM 40mg and 80mg once-daily oraltablets have been approved in the US and Brazil for 1st-line EGFRm advanced NSCLC, and in many other countries including the US, EU, Japan and China for patients with EGFR T790M mutation-positive advanced NSCLC.

About AstraZeneca :

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 three therapy areas –Cardiovascular Renal and Metabolic Disease, Oncology and Respiratory and Autoimmunity. The Company is also active in inflammation, infection and neuroscience through numerous collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Many studies have suggested that nearlyall the lung cancer cases are non-small cell lung cancers (NSCLC), of which EGFR-TKI sensitisingmutations are observed in 23 – 50% of patients. These patients are particularly sensitive to EGFRTKIs,which blocks the cell-signaling pathways that drive the growth of tumour cells. But, tumoursalmost always develop resistance to EGFR-TKI treatment, which leading to disease progression.

Nearly 28-54% of EGFRm advanced NSCLC patients, whose disease progresses after treatment withan EGFR TKI, develop resistance due to the T790M resistance mutation. There is also a need formedicines with improved CNS efficacy since approximately 16% patients with EGFRm NSCLC havebrain 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 EGFRsensitising(exon 19 deletions or exon 21 (L858R) substitutions mutations) and EGFR T790Mresistancemutations, with clinical activity against CNS metastases.

About AstraZeneca Pharma India Limited :

AstraZeneca Pharma India Limited was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited has a workforce of over 1200 employees across the country that is committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization.


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