Last Updated on August 1, 2025 by The Health Master
CDSCO approval
AstraZeneca Pharma India has secured an important Central Drugs Standard Control Organisation approval (CDSCO approval).
This CDSCO approval allows the import and distribution of Durvalumab solution for infusion, increasing its reach for the treatment of muscle-invasive bladder cancer (MIBC).
This landmark CDSCO approval redefines the treatment landscape for thousands of patients suffering with this form of cancer.
The newly CDSCO approval of Durvalumab marks an important milestone towards a more comprehensive treatment approach.
It now allows for the use of Durvalumab in combination with gemcitabine and cisplatin as a neoadjuvant treatment—meaning administered before surgery—followed by single-agent Durvalumab as an adjuvant treatment after radical cystectomy.
This is particularly designed for adult patients diagnosed with MIBC, offering a potent new weapon in the fight against a highly challenging disease.
Understanding the Bladder Cancer
Bladder cancer, unfortunately, remains a health challenge worldwide.
It consistently ranks among the top 10 most prevalent cancers globally, impacting a large portion of the population.
The statistics are stark: in 2022 alone, over 600,000 new cases were diagnosed, leading to more than 220,000 deaths globally.
India, too, bears a considerable burden from this disease.
In the same year, the nation recorded approximately 22,500 new cases, with a tragic toll of over 12,000 deaths.
These figures underscore the urgent need for new and effective treatment strategies, a need that Durvalumab’s expanded approval aims to address.
The Science Behind the Approval:
The foundation for this CDSCO approval rests firmly on robust clinical evidence, particularly from the pivotal Phase III NIAGARA trial.
Dr. Sandeep Arora, Director of Medical Affairs at AstraZeneca Pharma India, elaborated on the trial’s impressive findings.
The NIAGARA trial meticulously evaluated the efficacy and safety of this perioperative regimen in patients afflicted with MIBC, yielding highly promising results.
Durvalumab’s Expanding Portfolio in India
It’s important to note that Durvalumab is not a newcomer to the Indian pharmaceutical landscape.
Prior to this latest CDSCO approval, it had already secured a place in the therapeutic arsenal for several other challenging cancers.
Indications for Durvalumab in India:
- Non-small cell lung cancer
- Small cell lung cancer
- Biliary tract cancers
- Hepatocellular carcinoma
- Endometrial cancer
Q: What is Durvalumab and how does it work?
A: Durvalumab is a human monoclonal antibody that targets PD-L1 (Programmed Death-Ligand 1). By blocking PD-L1, Durvalumab helps to unleash the body’s immune system to recognize and attack cancer cells. This type of treatment is known as immunotherapy.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Disclaimer: The information we have provided is for general knowledge and for informational purpose only and it cannot be treated as medical advice. Always consult your doctor for any health issues and / or for the treatment of the same. The Health Master does not claim responsibility for this information.
CDSCO approval granted for Liraglutide drug
Online Registration of Cosmetics in India: CDSCO
CDSCO approval granted for Durvalumab for Limited-Stage SCLC in India
CDSCO Approval: For Vedolizumab Biosimilar Clinical Trial
USFDA issues Warning Letter to Glenmark: Indore Plant
Apply WHO-GMP & CoPPs online: Step by step procedure
Drug recall: Granules recalls 33,000 bottles of BP drug
NPPA fixed retail price of 71 formulations: July 2025
Key Notes on Revised Schedule M: API Part-7
Seminar held for Pharma Industry: IPGA
No Loan License Needed for Outsourced Medical Device Sterilization
66th meeting of the Drugs Consultative Committee (DCC): Gist
