What Is Imfinzi Durvalumab, The Cancer Drug That Just Got Approval For Use In India?

In a major pharma development, AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO) to sell and distribute Durvalumab solution for an additional indication, aiming to support cancer treatment in India. The drug company has mentioned that Durvalumab, in combination with carboplatin and paclitaxel, is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer. It is used in combination with chemotherapy, followed by monotherapy for dMMR patients.

What is Durvalumab? How does it help improve cancer treatment?

Durvalumab, commonly known by the brand name Imfinzi, is a type of immunotherapy medication used to treat various cancers, including non-small cell lung cancer, small cell lung cancer, biliary tract cancer, liver cancer, and endometrial cancer. It acts as a checkpoint inhibitor by blocking PD-L1 (Programmed Death-Ligand 1), allowing the immune system to attack cancer cells.

Unlike traditional chemotherapy, which attacks rapidly dividing cells (both healthy and cancerous), Durvalumab helps your own immune system recognise and destroy cancer cells. It targets a specific protein called PD-L1.

How it works

Cancer cells often escape from the immune system by using the PD-L1 protein as a cloaking device. This protein sends a 'do not attack' signal to your T-cells, a type of white blood cell that are called the soldiers of your immune system.

Durvalumab blocks this signal. By neutralising PD-L1, the drug effectively pulls the mask off the cancer cells, allowing your immune system to find and kill them.

Key uses

Durvalumab is used across several different types of aggressive cancers, often when the cancer is advanced or has spread.

1. Lung cancer

Non-small cell lung cancer (NSCLC): Durvalumab is used as the standard maintenance therapy for patients with Stage III lung cancer who can't undergo surgery but haven't gotten worse after initial chemotherapy and radiation.

Small cell lung cancer (SCLC): It is used as the first-line treatment for advanced SCLC, together with chemotherapy.

2. Biliary tract cancer (BTC)

This treatment is used with chemotherapy for cancers in the bile ducts or gallbladder that have spread or cannot be removed by surgery.

3. Liver cancer (Hepatocellular Carcinoma)

Durvalumab is used in combination with another immunotherapy drug (Tremelimumab) to treat adults with advanced liver cancer that can't be surgically removed.

4. Endometrial cancer

A more recent approval allows it to be used alongside chemotherapy for adults with primary advanced or recurrent endometrial cancer.

5. Gastric (Stomach) cancer

This treatment is used before and after surgery to lower the chances of the cancer coming back in patients with operable stomach or gastroesophageal junction cancers.

Common side effects

As an immunotherapy, it can cause immune-related adverse reactions, which often involve inflammation. Common side effects include fatigue, muscle pain, cough, shortness of breath and rash. The immune system can also mistakenly attack healthy tissues, including the thyroid, lungs, liver, or colon.

How will this support cancer treatment outcomes in India?

The availability of Imfinzi's Durvalumab is expected to significantly shift the oncology landscape in India by introducing advanced immunotherapy to earlier, more treatable stages of cancer.

It will be available as a solution for infusion in two strengths: 120 mg/2.4 mL and 500 mg/10 mL for the specified additional indication.

Gastric cancer is the seventh most common cancer in India. It remains a major health challenge with over 64,000 new cases diagnosed annually. This drug introduces a first-of-its-kind immunotherapy option for these high-burden cases.

This approval can further help improve survival rates. Clinical trials have shown that adding Durvalumab post-chemoradiation significantly extends survival for small cell lung cancer (SCLC) compared to standard care.

It is also likely to reduce cancer recurrence in patients by focusing on perioperative use-treatment given before and after surgery. This approach aims to eliminate microscopic cancer cells, reducing the high risk of recurrence typically seen within two years of surgery.

For endometrial cancer, it provides a specific maintenance therapy for patients with dMMR genetic characteristics, offering a more personalised and effective alternative to broad chemotherapy.

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