AstraZeneca Pharma India (AZPIL) has received approval from the Central Drugs Standard Control Organisation (CDSCO) for an additional indication of trastuzumab deruxtecan in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer.
The approval covers patients whose tumours are HER2-positive, defined as immunohistochemistry (IHC) 3+ or in situ hybridisation (ISH) positive, and represents a new treatment option in a disease setting where unmet clinical need remains substantial.
Breast cancer is among the most common cancers affecting women globally, with HER2-positive disease considered one of the more aggressive subtypes. In India, HER2-positive breast cancer is estimated to account for approximately 12per cent to 19per cent of all breast cancer cases. Despite advances in treatment, outcomes for patients with metastatic HER2-positive disease remain challenging, particularly as a significant proportion of patients do not receive second-line therapy after disease progression.
The CDSCO approval is based on findings from the global DESTINY-Breast09 trial, which included patients from India. The study evaluated trastuzumab deruxtecan in combination with pertuzumab against the current standard THP regimen comprising a taxane, trastuzumab and pertuzumab.
Results from the trial demonstrated a statistically significant improvement in progression-free survival (PFS) among patients receiving the trastuzumab deruxtecan combination. According to the study, median PFS was 40.7 months in the trastuzumab deruxtecan plus pertuzumab arm compared with 26.9 months in the THP arm, translating to a 44per cent reduction in the risk of disease progression or death.
The clinical benefit was observed consistently across patient subgroups, supporting the combination’s role as a potential new first-line treatment option for HER2-positive metastatic breast cancer.
Praveen Rao Akkinepally, Country President and Managing Director of AstraZeneca Pharma India, said the approval could help address a significant treatment gap for patients with advanced HER2-positive breast cancer.
“For many patients, the initial treatment decision can shape outcomes across the course of their disease, making early access to innovation especially important. We remain committed to bringing important scientific advances to patients in India and improving access to innovative therapies,” he said.
Trastuzumab deruxtecan is already approved in India for several oncology indications, including unresectable or metastatic HER2-positive breast cancer after prior anti-HER2 therapy, HER2-low and HER2-ultralow breast cancers in specified settings, HER2-positive gastric or gastroesophageal junction adenocarcinoma following prior anti-HER2 treatment, and certain HER2-positive solid tumours where no satisfactory alternative treatment options exist.
The latest approval expands the use of the therapy into the first-line treatment setting and adds another option for oncologists managing advanced HER2-positive breast cancer. The decision also underscores the growing role of antibody-drug conjugates in transforming treatment outcomes across multiple cancer types.