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AstraZeneca Pharma India Secures CDSCO Approval for Enhertu in Breast Cancer

AstraZeneca Pharma India Ltd has received approval from the Central Drugs Standard Control Organization (CDSCO) to market Enhertu (Trastuzumab Deruxtecan) for a new indication.

Reader Takeaway: New breast cancer indication approval; enhances oncology portfolio.

What just happened

The Central Drugs Standard Control Organization (CDSCO) has approved the import and sale of Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion. This approval is for the neoadjuvant treatment of adult patients diagnosed with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.

The treatment regimen involves using Trastuzumab deruxtecan followed by a taxane, trastuzumab, and pertuzumab (THP).

Why this matters

This regulatory clearance allows AstraZeneca Pharma India to market Enhertu for an additional indication, significantly expanding the potential patient population for its oncology drugs in India. It signifies a key step in the company's strategy to grow its cancer treatment portfolio.

The backstory

Enhertu is a targeted therapy for HER2-positive cancers. This approval focuses on its use in the neoadjuvant setting, meaning before surgery, for specific stages of breast cancer.

What changes now

AstraZeneca can now commercially offer Enhertu for this specific early-stage breast cancer indication in India. The company will focus on the rollout of this treatment regimen.

Risks to watch

Further regulatory approvals may be required for specific aspects of marketing or distribution, though the primary clearance from CDSCO has been obtained.

Peer comparison

This approval strengthens AstraZeneca's position in the Indian oncology market, competing with other targeted therapies and chemotherapies available for breast cancer treatment.

Context metrics (time-bound)

The approval date from CDSCO is July 27, 2026.

What to track next

Investors should monitor the commercial performance and market uptake of Enhertu for this new indication, as well as any further updates on its application in other cancer types or stages.