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AstraZeneca Has Just Received India's Third Enhertu CDSCO Approval in 12 Months — Now for Neoadjuvant Early-Stage HER2-Positive Breast Cancer Before Surgery

By Mustafa Shariff, Editor in Chief · July 30,2026 · 2 min read

Mustafa Shariff, Editor in Chief — AstraZeneca Has Just Received India's Third Enhertu CDSCO Approval in 12 Months — Now for Neoadjuvant Early-Stage HER2-Positive Breast Cancer Before Surgery

Summary

  • AstraZeneca's Enhertu Gets Third CDSCO Approval in 12 Months: Neoadjuvant Treatment for HER2-Positive Stage II/III Breast Cancer in India
  • AstraZeneca Pharma India received CDSCO approval for Enhertu (trastuzumab deruxtecan) as neoadjuvant treatment for HER2-positive Stage II/III breast cancer — the molecule's third CDSCO clearance in under 12 months.

"This approval marks an important step forward in the management of early-stage HER2-positive breast cancer in India. Providing trastuzumab deruxtecan as a neoadjuvant option before surgery means we can intervene earlier in the disease journey — when the potential to eliminate residual tumour before resection is highest and when pathological complete response rates may translate into meaningful long-term benefit. Every additional tool we have to treat breast cancer earlier improves the probability of cure."

AstraZeneca Pharma India Limited announced on July 28, 2026 that the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, has approved an additional indication for trastuzumab deruxtecan 100mg/5mL (Enhertu) — cleared for use as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or Stage III breast cancer, in a combination regimen with a taxane, trastuzumab, and pertuzumab (THP), administered before surgery.
This is the third CDSCO approval for trastuzumab deruxtecan in India within twelve months — the third time in twelve months that CDSCO has expanded this molecule's permitted use for Indian patients. The trajectory: October 2025, tumour-agnostic approval for HER2-positive solid tumours (any cancer type with HER2 expression). June 2026, approval for first-line treatment of metastatic HER2-positive breast cancer. July 28, 2026, approval for neoadjuvant treatment of HER2-positive Stage II/III early breast cancer. This rapid sequential expansion of indications for a single molecule reflects both the strength of the underlying clinical evidence and AstraZeneca's focused strategy of building Enhertu into India's leading oncology brand through the broadest possible approved indication set.
What Neoadjuvant Treatment Means for Early Breast Cancer
The distinction between neoadjuvant and adjuvant therapy in breast cancer is clinically significant. Adjuvant treatment — the conventional sequence — involves surgery first to remove the primary tumour, followed by systemic therapy to eliminate any residual cancer cells that may have spread beyond the surgical site. Neoadjuvant treatment reverses this sequence: systemic therapy is administered before surgery, with the goal of shrinking the tumour (and any lymph node involvement) before the surgeon operates.
The clinical rationale for neoadjuvant therapy in HER2-positive early breast cancer is compelling. First, it allows the oncologist to assess the tumour's response to treatment while it is still in place — if the tumour responds well, pathological complete response (pCR, the elimination of all invasive cancer in the breast and lymph nodes at the time of surgery) is achievable. Patients who achieve pCR have significantly better long-term outcomes than those who do not. Second, neoadjuvant therapy can downstage tumours — converting inoperable Stage III disease into operable disease, or converting mastectomy-required disease into breast-conserving surgery-eligible disease.
With currently used neoadjuvant regimens for HER2-positive breast cancer, pathological complete response is achieved in 39% to 64% of patients. These regimens are also associated with a range of acute and long-term toxicities. Enhertu's entry into the neoadjuvant setting is being investigated in the DESTINY-Breast11 trial with the aim of improving pCR rates, which could translate into better long-term survival outcomes for patients with Stage II and III disease.
AstraZeneca Pharma India's FY26 Context
The Enhertu neoadjuvant approval is the latest milestone in AstraZeneca Pharma India's sustained revenue transformation. The company reported FY26 revenue of ₹2,275.58 crore, up 32.6% year-on-year, with its oncology therapeutic segment leading at ₹1,610 crore — growing 43.1% year-on-year. This growth trajectory reflects the company's deliberate strategy of building its India portfolio around high-value specialty biologics and targeted therapies rather than competing in the generic pharmaceutical market where pricing pressure is relentless.
In India, HER2-positive breast cancer accounts for approximately 12% to 19% of all breast cancer cases. With India's annual breast cancer incidence exceeding 2.32 lakh cases (covered in BHC Media's May 26 edition), the HER2-positive patient population represents somewhere between 28,000 and 44,000 new patients annually — a commercially significant patient pool for a therapy that carries premium pricing.
BHC Perspective
At Bengaluru Health Community, AstraZeneca's third Enhertu CDSCO approval in twelve months illustrates what a focused oncology specialty portfolio strategy looks like in execution. Three CDSCO approvals in twelve months for the same molecule — each expanding access to different patient populations, each strengthening the brand's clinical positioning — reflects the kind of regulatory affairs speed and clinical programme depth that defines leadership in India's specialty oncology market. For BHC founders in oncology technology, HER2 diagnostics, or precision cancer therapy — Enhertu's rapid India approval trajectory is a model of how global biotech brings breakthrough cancer medicines to Indian patients.
Frequently Asked Questions
Q: What is AstraZeneca's new Enhertu CDSCO approval?
A: Neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or Stage III breast cancer, in combination with taxane, trastuzumab, and pertuzumab (THP), before surgery — the third CDSCO clearance for trastuzumab deruxtecan (Enhertu) in India within twelve months.
Q: What is neoadjuvant treatment?
A: Systemic therapy administered before surgery (instead of after). In early breast cancer, it allows tumour response assessment before surgery, can downstage inoperable tumours, and — when pathological complete response is achieved — is associated with better long-term outcomes. Currently, pCR is achieved in only 39-64% of patients with existing neoadjuvant regimens.
Q: What is AstraZeneca Pharma India's recent performance?
A: FY26 revenue ₹2,275.58 crore (+32.6% YoY), led by the oncology segment at ₹1,610 crore (+43.1% YoY). The third Enhertu CDSCO approval reflects a broader strategy of building India's oncology portfolio around high-value specialty biologics rather than generic pharmaceutical competition.