New Delhi
The approval strengthens cancer therapy options in India with wider use of Durvalumab immunotherapy for patients.
AstraZeneca Pharma India Limited on Tuesday announced that it has received approval from the Central Drugs Standard Control Organisation to sell and distribute Durvalumab for an additional cancer indication. The approval allows the use of Durvalumab in combination with carboplatin and paclitaxel as first line treatment for adults with advanced or recurrent endometrial cancer who need systemic therapy. After initial treatment, patients will receive Durvalumab alone as maintenance therapy in cases where the cancer is mismatch repair deficient.
The company said the permission covers Durvalumab solution for infusion in 120 mg and 500 mg doses, sold under the brand name Imfinzi. The approval clears the way for marketing the drug in India, subject to other statutory requirements.
Earlier, the regulator had also approved Durvalumab with FLOT chemotherapy for patients with resectable gastric and gastroesophageal junction cancer. This decision was based on results from the phase three MATTERHORN study. The study showed that adding immunotherapy before and after surgery can reduce the risk of cancer returning and improve long term survival.
Gastric cancer is a serious health concern in India, with over sixty four thousand new cases every year. Although surgery and chemotherapy remain standard care, survival rates are still low and recurrence is common.
Praveen Rao Akkinepally, Managing Director of AstraZeneca Pharma India, said the new approvals bring immunotherapy earlier into treatment. He added that these steps aim to improve outcomes and offer patients better chances of survival and quality of life.
The company stated that the latest CDSCO decision reflects continued confidence in scientific evidence and global studies. It also signals growing availability of advanced cancer medicines in India, supporting doctors with newer options and strengthening patient access to treatments nationwide.