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AstraZeneca Gains Approval for Enhertu in India, Expanding Cancer Treatment Options


Updated: May 08, 2025 15:10

Image Source : The Economic Times
AstraZeneca Pharma India Ltd. has received regulatory approval for Enhertu, a breakthrough cancer therapy designed for patients with HER2-positive metastatic breast cancer. The approval marks a significant advancement in oncology treatment, offering new hope for individuals who have previously undergone anti-HER2 therapies.
 
Enhertu, developed in collaboration with Daiichi Sankyo, is an antibody-drug conjugate that specifically targets HER2 receptors, delivering a potent chemotherapy payload directly to cancer cells. The drug has demonstrated remarkable efficacy in clinical trials, significantly improving progression-free survival rates compared to existing treatments.
 
The approval from the Drug Controller General of India allows AstraZeneca to import and market Enhertu for patients with unresectable or metastatic HER2-positive breast cancer. Additionally, the drug has received clearance for treating HER2-low metastatic breast cancer and HER2-positive gastric cancer, expanding its potential impact across multiple cancer types.
 
India has witnessed a sharp rise in breast cancer cases over the past two decades, making advanced treatment options like Enhertu crucial for improving patient outcomes. The drug’s introduction aligns with AstraZeneca’s broader commitment to redefining cancer care and enhancing accessibility to innovative therapies.
 
Regulatory Approval Highlights:
  • AstraZeneca receives approval for Enhertu in India for HER2-positive metastatic breast cancer.
  • The drug is an advanced antibody-drug conjugate developed with Daiichi Sankyo.
  • Enhertu also approved for HER2-low breast cancer and HER2-positive gastric cancer.
  • Clinical trials show significant improvement in progression-free survival rates.
  • Approval supports AstraZeneca’s mission to expand cancer treatment accessibility.
Sources: AstraZeneca India, Economic Times, Business Standard, Financial Express, Moneycontrol.

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