NEW DELHI, India — AstraZeneca Pharma India Ltd. said it has received regulatory approval from India’s drug authority to market Durvalumab for an additional cancer indication, expanding the treatment options available to patients with endometrial cancer.
In a stock exchange filing, the company said the Central Drugs Standard Control Organisation has granted permission to import, sell, and distribute Durvalumab solution for infusion for a new use. Under the approval, Durvalumab, in combination with carboplatin and paclitaxel, is indicated as a first-line treatment for adults with primary advanced or recurrent endometrial cancer who are eligible for systemic therapy. The regimen is followed by maintenance treatment with Durvalumab as monotherapy in patients whose cancer is mismatch repair deficient.
The approval covers Durvalumab solution for infusion in 120 mg/2.4 mL and 500 mg/10 mL doses, marketed under the brand name Imfinzi. The company said the permission enables it to proceed with marketing the drug in India for the additional indication, subject to any remaining statutory clearances.
AstraZeneca Pharma India noted that the latest approval builds on earlier regulatory clearances for Durvalumab in other cancer settings. The drug had previously received approval for use in combination with FLOT chemotherapy as a perioperative immunotherapy option for adults with resectable gastric or gastroesophageal junction adenocarcinoma, based on evidence of survival benefit.
That approval was supported by results from the phase III MATTERHORN study, which demonstrated that adding Durvalumab to FLOT chemotherapy in both neoadjuvant and adjuvant settings, followed by Durvalumab as a single agent, could reduce recurrence risk and improve long-term outcomes.
Gastric cancer continues to pose a significant public health challenge in India, ranking among the most commonly diagnosed cancers and leading causes of cancer-related deaths. Although about half of gastric and gastroesophageal junction cancers are detected at a resectable stage, five-year survival rates remain below 50 percent despite standard treatment, with high rates of recurrence within two years of surgery.
“We are transforming cancer care in India. Patients with resectable gastric and gastroesophageal junction cancers face high recurrence risk. Backed by the MATTERHORN study, this approval brings immunotherapy earlier in the treatment pathway, significantly improving survival,” said Praveen Rao Akkinepally, Country President and Managing Director of AstraZeneca Pharma India Ltd. (Source: IANS)
