AstraZeneca Pharma India Ltd. (AZPIL) announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan 100 mg/5 mL vial lyophilized 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.
In India, HER2-positive breast cancer, defined by HER2 gene amplification or protein overexpression, is estimated to account for approximately 12% to 19% of breast cancer cases. In the metastatic setting, unmet need remains significant. Despite advances in care, no new first-line therapies have enhanced outcomes for patients with HER2-positive metastatic breast cancer in recent years. In addition, approximately one-third of patients treated in the first-line setting do not go on to receive second-line therapy, highlighting the importance of using the more effective treatment early in the course of the disease.
The approval is based on results from the DESTINY-Breast09 trial, which included patients from India. In this trial, Trastuzumab Deruxtecan plus Pertuzumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) by blinded independent central review (BICR) as compared to the THP (taxane, trastuzumab and pertuzumab) regime. Median PFS was 40.7 months for Trastuzumab Deruxtecan plus Pertuzumab compared with 26.9 months for THP, representing a 44% reduction in the risk of disease progression or death. The benefit was consistently 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. At AstraZeneca, our purpose is to transform patient outcomes through science, and we are committed to accelerating the introduction of important new medicines in 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.
This approval reinforces AstraZeneca’s commitment to advancing treatment options for patients with breast cancer and addressing persistent unmet needs through science-led innovation.
