Tagrisso to treat NSCLC in IndiaSeptember 14, 2018
The Drug Controller General of India granted import and market permission for osimertinib (Tagrisso) tablet with 40 mg and 80 mg strengths as a first-line treatment for EGFRm advanced non-small cell lung cancer (NSCLC).
The receipt of this permission paves the way for the launch of osimertinib in India, said AstraZeneca Pharma India Limited .
Osimertinib is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Osimertinib is already approved and available for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
In 2017, osimertinib was granted ‘Breakthrough Therapy’ status and ‘Priority Review’ designations by the US FDA in 1st line treatment setting.