AstraZeneca Pharma India Gets CDSCO Nod for Additional Indication of Osimertinib

AstraZeneca Pharma India Ltd. on Friday said it has received approval from the Central Drugs Standard Control Organization (CDSCO) to import and distribute Osimertinib tablets (Tagrisso) in 40 mg and 80 mg strengths for an additional indication.

The approval allows the use of Osimertinib in combination with pemetrexed and platinum-based chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

AstraZeneca said the marketing of the drug in India for this additional indication will proceed following any further required statutory approvals.