CDSCO approves Trastuzumab Deruxtecan for first-line HER2-positive breast cancer

AstraZeneca Pharma India (AZPIL) announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion, in combination with Pertuzumab, as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer.

Breast cancer remains one of the most common cancers affecting women worldwide, while HER2-positive breast cancer is among its forms. In India, HER2-positive breast cancer, defined by HER2 gene amplification or protein overexpression, is estimated to account for approximately 12 to 19 per cent of breast cancer cases.

According to AstraZeneca, unmet need remains significant in the metastatic setting. The company stated that no new first-line therapies have enhanced outcomes for patients with HER2-positive metastatic breast cancer in recent years. It further noted that approximately one-third of patients treated in the first-line setting do not go on to receive second-line therapy, highlighting the importance of treatment in the early course of disease.

The approval is based on results from the DESTINY-Breast09 trial, which included patients from India. In the trial, Trastuzumab Deruxtecan plus Pertuzumab demonstrated a statistically significant improvement in progression-free survival (PFS) by blinded independent central review (BICR) compared with the THP regimen comprising taxane, trastuzumab and pertuzumab.

Median progression-free survival was 40.7 months for Trastuzumab Deruxtecan plus Pertuzumab compared with 26.9 months for THP, representing a 44 per cent reduction in the risk of disease progression or death. According to the company, the benefit was observed across subgroups.

Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited, said, “This approval marks an important step forward for patients with unresectable or metastatic HER2-positive breast cancer in India, where the need for more effective treatment options in the first-line setting remains high. For many patients, the initial treatment decision can shape outcomes across the course of their disease, making early access to innovation especially important. At AstraZeneca, our purpose is to transform patient outcomes through science, and we are committed to accelerating the introduction of important new medicines to India, helping patients access advances in care sooner while working with the broader healthcare ecosystem to reduce barriers and improve quality of life.”

Current approved indications for trastuzumab deruxtecan include the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen; HER2-low and HER2-ultralow breast cancer in specified metastatic settings; locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma following a prior anti-HER2-based regimen; and other unresectable or metastatic HER2-positive (IHC 3+) solid tumours after prior systemic treatment where no satisfactory alternative treatment options exist.

AstraZeneca stated that the approval expands treatment options for patients with breast cancer and supports its efforts to address unmet need through science-led innovation.