AstraZeneca India Pharmaceuticals Ltd (AZPIL), a global science-led and patient-centric pharmaceutical company, announced that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market trastuzumab deruxtecan concentrate (100 mg) for an additional indication in India.
Expanding Treatment Options for HER2-Low and HER2-Ultra-Low Breast Cancer
Previously approved as a monotherapy for adult patients with unresectable or metastatic HER2-low breast cancer (IHC 1+ and IHC 2+/ISH-) who had undergone at least one prior endocrine therapy, trastuzumab deruxtecan now extends its indication to also include patients with HER2-ultra-low expression (IHC 0, membrane staining).
This approval stems from the pivotal results of the DESTINY-Breast06 trial, which demonstrated the drug’s superior efficacy compared to chemotherapy in hormone receptor-positive, HER2-low and HER2-ultra-low metastatic breast cancer patients.
Addressing a Growing Medical Need in India
Breast cancer remains the most commonly diagnosed cancer worldwide, according to the World Health Organization (WHO), with over 2 million new cases in 2020. In India, breast cancer incidence has surged by 40% over the past 25 years, underscoring the urgent need for effective therapies tailored to local patient populations.
Dr. Sandeep Arora, Director of Medical Affairs at AZPIL, highlighted the significance of the approval:
“This approval opens a new avenue for diagnosis and treatment of metastatic breast cancer in India. It emphasizes the importance of performing immunohistochemistry (IHC) testing to identify patients with HER2-low and HER2-ultra-low tumors who have progressed on endocrine therapy, thereby improving clinical outcomes.”
Clinical Trial Results Support Superior Progression-Free Survival
The DESTINY-Breast06 trial compared trastuzumab deruxtecan to investigator’s choice chemotherapy in patients who had received prior endocrine therapy but no metastatic chemotherapy. Results showed a marked improvement in progression-free survival (PFS) for the trastuzumab deruxtecan group:
Median PFS of 13.2 months (95% CI, 11.4 to 15.2) vs. 8.1 months (95% CI, 7.0 to 9.0) for chemotherapy
Hazard ratio for disease progression or death was 0.62 (95% CI, 0.51 to 0.74; P<0.001), favoring trastuzumab deruxtecan
These findings validate trastuzumab deruxtecan’s role as a promising targeted treatment for patients with limited options.
AstraZeneca’s Commitment to Precision Oncology
Sanjeev Panchal, Country President and Managing Director of AZPIL, expressed the company’s commitment:
“We are leading the revolution in oncology by delivering innovative, science-driven therapies. AstraZeneca’s diversified portfolio addresses some of the most challenging cancers and strives to improve patient outcomes and quality of life.”
Trastuzumab deruxtecan was first launched in India in 2024 and is approved for three indications including breast and gastric cancers. The latest approval reinforces its growing impact on oncology care.
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