AstraZeneca India Gets CDSCO Nod for Bladder Cancer Treatment

AstraZeneca Pharma India has obtained approval by the Central Drugs Standard Control Organisation (CDSCO) to import and market Durvalumab solution for infusion with an expanded indication in India.

The new approval means that Durvalumab can be administered on a neoadjuvant basis with the help of gemcitabine and cisplatin, and single-agent Durvalumab in an adjuvant setting after radical cystectomy. It is a perioperative immunotherapy cleared to be used in adult people who have muscle-invasive bladder cancer (MIBC).

Bladder cancer is one of the 10 most common cancers in the world, and the number of new cases detected in 2022 was more than 600,000 new cases, and deaths totaled 220,000. Only India had about 22500 new cases and more than 12000 related deaths in the previous year.

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This has gained the approval of AstraZeneca and Praveen Akkinepally, country President and managing director of AstraZeneca Pharma India, said, “We at AstraZeneca remain committed to being science-led and bringing transformative medicines to India and its patients.” 

He stressed the company's mission of AstraZeneca to fill treatment access gaps and speed time-to-access to the latest innovative treatments in high-burden markets such as India.

In India, the drug is already approved against non-small cell lung cancer, small cell lung cancer, biliary tract cancers, hepatocellular carcinoma, and endometrial cancer. This new approval gives AstraZeneca a wider presence in India with an oncology portfolio to carry out the promise of bringing innovative cancer therapies to patients and providing excellent outcomes to patients in several high-impact areas.