AstraZeneca Pharma India gains CDSCO approval for treating endometrial cancer in the country
Durvalumab in combination with carboplatin and paclitaxel is now also indicated for first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy
AstraZeneca Pharma India has received permission to import for sale and distribution of Durvalumab solution for infusion from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for two additional indications.
These new indications will benefit patients living with endometrial cancer, which is the most common type of uterine cancer. Durvalumab in combination with carboplatin and paclitaxel is now also indicated for 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).
According to World Health Organisation, more than four lakh cases of Endometrial Cancer were diagnosed in 2022 with >17000 cases newly detected in India. The incidence of Endometrial Cancer is projected to increase by >20 per cent globally and in India. Praveen Akkinepally, Country President and Managing Director, AstraZeneca Pharma India, said, “We are truly proud to announce the regulatory approval of Durvalumab for the treatment of endometrial cancer in India. This important milestone is a testament to our commitment to advancing cancer care and bringing innovative therapies to patients who need them most.”
Dr. Sandeep Arora, Director Medical Affairs, AstraZeneca Pharma India, said, “In DUO E Study, Durvalumab in combination with Olaparib demonstrated a statistically significant 53 per cent lower risk of disease progression or death versus control with median Progression Free Survival 15.0 v 9.7 months in endometrial cancer with pMMR. MMR is an established biomarker in guiding immunotherapy treatment in such patients. This is a significant advancement over current Standard of care where addition of Durvalumab and Olaparib presents an opportunity to improve clinical outcomes of patients with Endometrial Cancer”
Durvalumab is already approved for Non-small Cell Lung Cancer, Small Cell Lung Cancer, Biliary Tract Cancers and Hepatocellular Cancer in India
References:
- https://gco.iarc.who.int/today/en/dataviz/bars?mode=population&key=total&cancers=24&populations=356_900&sexes=2&types=0&sort_by=value0 . [Date Accessed on: 30 Jun 2025]
- Sung H , et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. Global Cancer Statistics. doi: 10.3322/caac.21660. Available online at cacancerjournal.com
- Westin SN, Moore K, Sook Chon H, Lee, JY, Pepin JT, Sundborg M, et al. Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab With or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial. J Clin Oncol 42:283-299. https://doi.org/10.1200/JCO.23.02132