New Delhi: AstraZeneca Pharma India said it has received import and market permission from the Drug Controller General of India (DCGI) for Osimertinib (Tagrisso) tablets, prescribed as a first-line treatment for certain kinds of lung cancer.
AstraZeneca Pharma said approval has been granted for the product in the strengths of 40 mg and 80 mg.
“The receipt of this permission paves way for the launch of Osimertinib in India for first-line treatment. Osimertinib is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer,” the company said in a BSE filing.
AstraZeneca Pharma said in 2017, Osimertinib was granted ‘Breakthrough Therapy’ status and ‘Priority Review’ designations by the USFDA in a first-line treatment setting.
“Osimertinib is a patented product of AstraZeneca group,” the company said.
Lung cancer is the leading cause of cancer-related mortality worldwide and amongst males in India with 5-year survival rates as dismal as 3.7 percent in the country, it added.