AstraZeneca Pharma India has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan (Enhertu) 100 mg/5 mL, allowing its use in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The approval covers patients whose tumors are classified as HER2-positive through IHC 3+ or ISH+ testing.
The approval marks an important expansion for Enhertu in India, enabling eligible patients to receive the therapy earlier in their treatment journey. HER2-positive breast cancer is considered one of the more aggressive forms of the disease and accounts for an estimated 12% to 19% of breast cancer cases in India. Despite advancements in treatment, many patients with metastatic disease continue to face limited options and poor long-term outcomes.
The CDSCO decision is supported by findings from the global Phase III DESTINY-Breast09 clinical trial. The study demonstrated that the combination of trastuzumab deruxtecan and pertuzumab significantly improved progression-free survival compared with the current standard first-line regimen consisting of a taxane, trastuzumab, and pertuzumab (THP). Patients receiving the new combination achieved a median progression-free survival of 40.7 months, compared with 26.9 months for those treated with the standard regimen, representing a 44% reduction in the risk of disease progression or death.
According to AstraZeneca, the approval addresses a critical unmet need in metastatic HER2-positive breast cancer. The company noted that a substantial proportion of patients treated in the first-line setting do not proceed to receive second-line therapy, making the effectiveness of initial treatment especially important.
The latest approval further strengthens AstraZeneca’s oncology portfolio in India and expands access to innovative targeted therapies for patients battling advanced breast cancer. With Enhertu now available as a first-line option in combination with pertuzumab, oncologists may have an opportunity to improve outcomes and extend disease control for patients diagnosed with this aggressive subtype of breast cancer.
