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AstraZeneca Pharma India received CDSCO approval to import and distribute Durvalumab (Imfinzi) for an additional cancer treatment. The drug will target NSCLC with chemotherapy in India, expanding its therapeutic applications
AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Durvalumab (Imfinzi) for an additional indication in the Indian market. This approval will allow AstraZeneca to bring its cancer drug to patients who require specific treatments for non-small cell lung cancer (NSCLC) in combination with chemotherapy.
This development marks an important step in the company’s efforts to expand its portfolio of cancer treatments available in India.
Durvalumab, marketed as Imfinzi, is already used to treat certain types of cancer globally. The approval from CDSCO opens the door for the drug to be used in combination with chemotherapy as a neoadjuvant treatment. This will be followed by Durvalumab monotherapy after surgery, specifically for patients with resectable NSCLC that involves tumours 4 cm or larger, and node-positive cases.
The approval covers two dosage strengths: 120 mg/2.4 mL and 500 mg/10 mL solutions for infusion. This addition will provide more treatment options for cancer patients in India, helping to address cases where other treatments are ineffective.
The new indication focuses on patients with non-small cell lung cancer (NSCLC) who do not have known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. This specific group of patients with resectable tumours will benefit from the combination of Durvalumab and chemotherapy, as well as the continued use of Durvalumab post-surgery.
By expanding the range of its cancer drug treatments, AstraZeneca aims to strengthen its presence in India’s oncology market.
Following this announcement, shares of AstraZeneca Pharma India closed at ₹6,749 on the BSE, reflecting a 1.65% decline. Despite the drop, the company’s stock remains of interest as its ongoing advancements in the pharmaceutical sector continue to make headlines. The approval of Durvalumab for a new indication is expected to contribute to AstraZeneca’s growth in the Indian market.
This approval further establishes AstraZeneca’s commitment to improving cancer treatment options in India, reinforcing its standing in the country's pharmaceutical industry.
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