According to the company’s press statement, the approval was based on results from the OlympiA Phase III trial, which suggested that Olaparib demonstrated a statistically significant and clinically meaningful improvement, with an overall survival benefit.
AstraZeneca India on Friday announced that it has received the Drugs Controller General of India (DCGI) approval to market its drug Lynparza (Olaparib) as a monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2- negative high-risk early breast cancer, who have previously been treated with neoadjuvant or adjuvant chemotherapy.
According to the company’s press statement, the approval was based on results from the OlympiA Phase III trial, which suggested that Olaparib demonstrated a statistically significant and clinically meaningful improvement, with an overall survival benefit.
With the DCGI’s approval, Lynparza is now approved in the US, EU, Japan, India and several other countries for the treatment, the company claims. Currently, Lynparza is the first and only approved medicine targeting BRCA mutations in early-stage breast cancer, the company stated.
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“We are constantly pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. At AstraZeneca, the larger impetus is on redefining the treatment paradigm to eliminate the terminal nature of the disease. The regulatory approval of Lynparza, the first and only drug targeting BRCA mutations in early breast cancer, reinforces our growing capabilities in innovation and clinical research for providing holistic solutions for cancer treatment in India,” Gagandeep Singh, Managing Director and Country President, AstraZeneca India, said in a statement on Friday.
With an estimated 2.3 million patients diagnosed per year, Breast cancer is one of the most diagnosed cancer worldwide. According to experts, early diagnosis and biomarker testing play a critical role in identifying high-risk patients and improving patient outcomes by preventing disease recurrence.
Earlier this month, AstraZeneca’s drug Lynparza, developed with U.S.-based Merck & Co, was approved by the European Union as an adjuvant treatment for patients with a form of genetically mutated early-stage breast cancer.AstraZeneca’s Lynparza gets EU approval for treatment of early-stage breast cancer
