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AstraZeneca's Imfinzi Gets CDSCO Nod for New Endometrial Cancer Use

AstraZeneca Pharma India has received CDSCO approval to market Durvalumab (Imfinzi) for a new indication in treating primary advanced or recurrent endometrial cancer. This follows a previous approval for the drug's use in combination with chemotherapy for resectable gastric cancers. The approvals are based on clinical studies, including the phase III MATTERHORN trial, aiming to improve survival and reduce recurrence. Gastric cancer is a significant health challenge in India, with high recurrence rates despite current treatments.

Key Points: AstraZeneca's Durvalumab Approved for New Cancer Indication in India

  • New CDSCO approval for Durvalumab
  • For advanced endometrial cancer treatment
  • Also approved earlier for gastric cancer
  • Aims to reduce recurrence risk
  • Based on MATTERHORN study results
3 min read

AstraZeneca Pharma India receives CDSCO approval for Durvalumab indication in cancer treatment

CDSCO approves AstraZeneca's Durvalumab (Imfinzi) for advanced endometrial cancer treatment, expanding its use in India's oncology portfolio.

"We are transforming cancer care in India. - Praveen Rao Akkinepally"

New Delhi, Feb 10

AstraZeneca Pharma India Limited on Tuesday said it has received permission from the Central Drugs Standard Control Organisation to sell and distribute Durvalumab solution for infusion used in cancer treatment for an additional indication.

In its latest stock exchange filing, the drug company said that through this approval, "Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)".

According to the filing, "This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL (Brand Name: Imfinzi) for an additional indication," said AstraZeneca Pharma India Ltd.

The receipt of this permission paves way for the marketing of Durvalumab Solution for "Infusion 120 mg/2.4 mL and 500 mg/10 mL (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any," the filing further said.

Earlier, AstraZeneca Pharma India had announced the CDSCO approval for Durvalumab in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) as the first and only perioperative immunotherapy approach for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC), showing survival benefit.

Based on the results from the 'phase III MATTERHORN' study, the approval allows the addition of Durvalumab to FLOT chemotherapy for patients in the neoadjuvant and adjuvant settings, followed by single agent durvalumab, reflecting a comprehensive perioperative approach aimed at reducing recurrence risk and improving long-term outcomes.

Gastric cancer remains a major health challenge in India, ranking as the seventh most common cancer with over 64,000 new cases diagnosed annually, and the sixth leading cause of cancer-related deaths.

Around half of gastric and gastroesophageal junction cancers are diagnosed at a resectable stage, where surgery combined with peri-operative chemotherapy is the standard of care. Despite treatment with FLOT, five-year survival remains below 50%, and recurrence rates are high within two years of surgery, underscoring the need for more effective peri-operative options.

"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, AstraZeneca Pharma India Limited.

- IANS

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Reader Comments

R
Rajesh Q
Good step by CDSCO. But the real test is affordability. These advanced immunotherapies are notoriously expensive. Will this be available in government hospitals or only in private chains? The article mentions "subject to statutory approvals" – hope that includes price control negotiations.
A
Aman W
As someone in the pharma sector, this is significant. Durvalumab (Imfinzi) is a key drug globally. Getting additional indications approved in India speeds up access for patients here. The focus on gastric cancer is crucial given how common it is in our population.
S
Sarah B
Reading about the MATTERHORN study results is encouraging. Improving the 5-year survival rate for gastric cancer is a huge deal. Hope oncologists across India are trained and ready to incorporate this perioperative approach. Timely access can save lives.
V
Vikram M
Always good to see regulatory approvals keeping pace. But we must also invest in early detection. So many cases are diagnosed at advanced stages. Awareness campaigns and screening are equally important alongside new drugs.
N
Nisha Z
This is progress. My mother is a survivor. Every new treatment option is a ray of light. Kudos to the researchers and regulators. Now, please make it available without patients having to run from pillar to post for approvals and loans.

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