AstraZeneca Pharma India gets CDSCO nod for expanded use of Imfinzi in Endometrial 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, Durvalumab in combination with carboplatin and paclitaxel is indicated 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).
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.
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.
Read also: AstraZeneca Pharma India secures CDSCO nod to import, sell Durvalumab for small cell lung cancer
AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.
It is a listed company and is a subsidiary of AstraZeneca Plc, UK.
Read also: AstraZeneca Pharma India names Praveen Rao Akkinepally as new MD, succeeding Dr Sanjeev Panchal
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