AstraZeneca India gets CDSCO nod to import, distribute Osimertinib drug

AstraZeneca Pharma India Limited has received the authorization from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, to import and market Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) for a new indication.

Now, with this approval, Osimertinib has been included as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with tumors harboring deletions of EGFR exon 19 or mutations substituting exon 21 (L858R) when combined with pemetrexed and platinum-based chemotherapy.

Non-small cell lung cancer (NSCLC), the most common type of lung cancer, which grows and spreads much more slowly than small cell lung cancer usually, is used for both treatment indications. After the clearance, Osimertinib Tablets 40 mg & 80 mg (TAGRISSO) are authorized for marketing in India on the additional specified indication, provided that all requisite statutory permits are secured.

CDSCO has now bestowed the business wares application for importation of Durvalumab solution for infusion at 120 mg/2.4 ml and 500 mg/10 ml (Imfinzi) for commercial sale and distribution for yet another condition. This meant that, on approval, patients with limited-stage small cell lung cancer (LS-SCLC) presenting with no progression after platinum-based chemoradiation therapy (CRT) would now benefit from durvalumab, according to the sources.