DCGI approves osimertinib for EGFRm positive NSCLC

March 11, 2021 0 By FM

The drug controller of India (DCGI) has approved osimertinib (Tagrisso) for adjuvant treatment in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, announced Astra Zeneca.

The once-daily oral pill is administered to patients with lung cancer, whose tumour has a specific mutation called EGFR mutation and who have undergone surgical removal of the lung tumour.

The study on the drug has shown to decrease the risk of cancer recurrence by nearly 83% in the ADAURA clinical trial in early-stage lung cancer patients, said the company.

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 is one of the important cause of recurrence in early stage lung cancer. The drug has shown to decrease the chances of cancer spreading to the brain and other distant organs, revealed the company.

Early diagnosis and treatment of lung cancer is of utmost importance. However, even by providing the best treatment in early stages like surgery and post-surgery chemotherapy in eligible patients, more than half of the patients have a disease/cancer recurrence within 5 years. This is mainly attributed to the fact that cancer tends to recur again and there have been very few advances in treatment of early stage lung cancer. About 80%-90% of lung cancer cases are detected and diagnosed in the late stage, where the 5 years’ survival rate is less than 5% which leads to increased mortality rates, according to GLOBOCAN 2018 survey.

“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 potential therapeutic option to be given with curative intent to eligible select early lung cancer patients.” said Dr. Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India.