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 >17,000 cases newly detected in India. The incidence of endometrial cancer is projected to increase by >20% globally and in India.
 
Praveen Akkinepally, country president and managing director, AstraZeneca Pharma India Limited 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. It reinforces our dedication to transforming outcomes for women facing this difficult disease, and underscores our ambition to make a meaningful difference in the lives of patients across the country.”
 
Dr Sandeep Arora, director medical affairs, AstraZeneca Pharma India Limited said, "In DUO E study durvalumab in combination with olaparib demonstrated a statistically significant 53% 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.