AstraZeneca India bags dual CDSCO nod for Trastuzumab deruxtecan
Bangalore: AstraZeneca Pharma India Limited has received permission to import for sale and distribution of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India for two additional indications.
The new indications are:
HER2-Low Metastatic Breast Cancer: Trastuzumab deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-Low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
Locally Advanced or Metastatic Gastric Cancer: Trastuzumab deruxtecan is now indicated for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab based regimen.
"The receipt of this permission paves way for the launch of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg (Enhertu) in India for the specified additional indications, subject to the receipt of related statutory approvals, if any," the Company informed in a BSE filing,
Trastuzumab deruxtecan was earlier approved by Drug Controller General of India (DCGI), for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.
According to World Health Organisation, more than 2 million cases of breast cancer were diagnosed in 2020, making it the world’s most commonly diagnosed cancer. The incidence of breast cancer is low in India, but it is gradually rising with almost a 40% increase in cases, over the past 25 years. Gastric cancer on the other hand, ranks sixth most prevalent cancer in India affecting men, and poses a considerable challenge with a 5-year survival rate of less than 7% for those diagnosed at an advanced stage.
Dr Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said, “The approval of Trastuzumab deruxtecan signifies a pivotal moment in addressing unmet medical needs by introducing life-changing therapies to Indian patients. With this approval, we have the potential to significantly enhance outcomes for patients battling advanced or metastatic low HER-2 & HER-positive gastric cancers, especially those who have exhausted standard treatment options. Our commitment extends beyond treating symptoms; it encompasses our ambition to revolutionize cancer care, aiming to improve patient outcomes and ultimately eradicate cancer as a leading cause of death. We remain dedicated to fostering innovation, collaborating closely with the ecosystem, and expediting access to life-altering medications for patients in need."
Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, said, “Trastuzumab deruxtecan has demonstrated significantly improved overall survival and progression-free survival outcomes in patients with HER2-low metastatic breast cancer in DESTINY Breast 04 trial. The DESTINY Gastric 02 trial showed efficacy of Trastuzumab deruxtecan as second-line therapy in patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer. Evidenced by the compelling outcomes of our rigorous clinical trials, it demonstrates our commitment to scientific leadership and innovation takes precedence in our relentless efforts to redefine cancer care.”
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