AstraZeneca gains CDSCO approval for treatment of muscle-invasive bladder cancer
Durvalumab in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Durvalumab as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with MIBC
AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO), to import and distribute Durvalumab solution for infusion for an additional indication in India.
The newly approved indication allows the use of Durvalumab in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Durvalumab as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC).
Bladder cancer is amongst the top 10 most common cancers worldwide, with over 600,000 new cases and 220,000 deaths reported globally in 2022. In India, 22,500 new cases and over 12,000 deaths were recorded in the same year.
Praveen Akkinepally, Country President and Managing Director, AstraZeneca Pharma India, said, “Introducing the first perioperative immunotherapy for muscle-invasive bladder cancer marks a significant step forward in improving outcomes and redefining standards of care.”
Dr. Sandeep Arora, Director of Medical Affairs, AstraZeneca Pharma India, added: “The approval is based on results from the pivotal Phase III NIAGARA trial, which evaluated the efficacy and safety of this perioperative regimen in patients with MIBC. The perioperative regimen demonstrated a 32 per cent reduction in the risk of disease progression, recurrence, or death, compared to the standard approach. The median event-free survival (EFS) was not yet reached in the Durvalumab group, versus 46.1 months in the comparator arm. At two years, 67.8 per cent of patients treated with the regimen were event-free, compared to 59.8 per cent in the control group.”
In addition, the overall survival (OS) data showed a 25 per cent reduction in the risk of death with the Durvalumab-based regimen. At two years, 82.2 per cent of patients were alive in the treatment arm versus 75.2 per cent in the comparator arm. Median OS has not yet been reached in either group.
Durvalumab is currently approved in India for the treatment of non-small cell lung cancer, small cell lung cancer, biliary tract cancers, hepatocellular carcinoma and endometrial cancer.