New Delhi: The Central Drugs Standard Control Organisation (CDSCO) have given AstraZeneca Pharma India Limitedthe approval to import and distribute Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg for two additional indications.
The newly approved uses are for treating HER2-Low Metastatic Breast Cancer and Locally Advanced or Metastatic Gastric Cancer. Trastuzumab deruxtecan is now approved for adult patients with HER2-Low breast cancer that cannot be removed by surgery or has spread, and for those who have had prior chemotherapy or developed recurrence within 6 months of finishing adjuvant chemotherapy.
It is also approved for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with trastuzumab.
Previously approved for HER2-positive breast cancer by the Drug Controller General of India (DCGI), this broader approval tackles important medical needs in India. Globally, breast cancer is the most commonly diagnosed cancer, with over 2 million cases in 2020. Gastric cancer, ranking sixth in prevalence in India, poses a challenge with a 5-year survival rate of less than 7% for those diagnosed at an advanced stage.