CDSCO grants approval to AstraZeneca India for Breakthrough Therapy of lung cancer

Through a recent notification, Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, has granted import and marketing approval to AstraZeneca Pharma India Limited for Osimertinib Film-coated Tablets 40mg/80mg (Osimertinib Mesylate) for lung cancer .

The permission is granted for the treatment of the patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC).

The notice states that the approval comes in pursuance to the Import and Market permission granted to M/s. Astra Zeneca Pharma India Limited, Bangalore, for Osimertinib Film-coated Tablets 40mg/80mg (as Osimertinib Mesylate), "For the treatment of patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy", on 29/05/2017. The drug alert issued vide F. No. 12-38/2017-DC (Pt-Misc-SND) dated 13/10/2017 shall stand withdrawn.

However, all the State Drugs Controllers, CDSCO zonal or sub-zonal offices and port officers were requested to have vigil on the illegal manufacture/import, sale or distribution of Osimertinib mesylate tablets as per the provisions of Drugs and Cosmetics Act and Rules thereunder.

Osimertinib is used to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC), when the cancer has the specific T790M mutation in the gene coding for epidermal growth factor receptor.

Osimertinib was designated as a Breakthrough Therapy in April 2014 based on Phase I trial results, and the drug was provisionally approved under the USFDA accelerated approval program with a priority review voucher, in November 2015.

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