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AstraZeneca Pharma gets DCGI nod for lung cancer treatment drug

The oral pill has shown to decrease the risk of cancer recurrence by nearly 83 per cent

AstraZeneca Pharma (AstraZeneca India) has received marketing approval for Tagrisso (Osimertinib) from Drugs Controller General of India (DCGI) for adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC), whose tumours have epidermal growth factor receptor (EGFR) mutations.

Gagandeep Singh Bedi, MD, Astrazeneca India said, “AstraZeneca has always been and will continue to bring forward world-class treatment solutions for non-communicable diseases. The regulatory approval of Tagrisso (Osimertinib) in India will provide better medicine for the management of non-small cell lung cancer and help patients attain a better quality of life.”

Osimertinib, a once-daily oral pill, when given to patients of lung cancer, whose tumour have a specific mutation called EGFR mutation and who have undergone surgical removal of the lung tumour, has shown to decrease the risk of cancer recurrence by nearly 83 per cent in the ADAURA clinical trial in early-stage lung cancer patients. Osimertinib is the first targeted oral treatment option to show such a significant benefit in terms of cancer-free survival in early lung cancers with EGFRm positivity. Cancer spread to the brain and other organs are one of the important cause of recurrence in early-stage lung cancer. Osimertinib has shown to decrease the chances of cancer spreading to the brain & other distant organs.

Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said, “AstraZeneca has always been on the forefront of an innovative solution for non-communicable diseases. Despite currently available therapies, a significant unmet need exists for effective management of EGFRm early stage Non-Small Cell Lung Cancer (NSCLC) in India. The approval of Osimertinib as an adjuvant treatment for EGFRm NSCLC in India will provide the much-needed treatment choice for patients in early lung cancers with EGFRm positivity. The approval will provide Oncologists with the potential therapeutic option to be given with curative intent to eligible select early lung cancer patients.”

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