AstraZeneca Pharma India receives CDSCO nod for expanded use of Imfinzi in bladder cancer
Bangalore: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) for an additional indication.
Through this approval, Imfinzi in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
The receipt of this permission paves way for the marketing of Durvalumab Solution for Infusion 120 mg/2.4 ml and 500 mg/10 ml (Brand name: Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.
This is the latest in a series of regulatory clearances AstraZeneca has received for expanded uses of Durvalumab in India. Earlier this month, CDSCO approved Durvalumab for another additional indication—in combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).
Read also: AstraZeneca Pharma India gets CDSCO nod for expanded use of Imfinzi in Endometrial Cancer
In March this year, AstraZeneca Pharma India received CDSCO approval to import for sale and distribution of Imfinzi for patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
Additionally, earlier in the same month, the company obtained permission for Durvalumab in combination with Tremelimumab for patients with unresectable hepatocellular carcinoma (uHCC). Hepatocellular carcinoma (HCC) is a type of liver cancer. Because symptoms often don’t appear until the advanced stages, getting diagnosed with liver cancer like HCC can come as a shock.
