AstraZeneca India, a leading science-led biopharmaceutical company, has announced that it has received approval from the Drugs Controller General of India (DCGI) to market its drug Lynparza (olaparib).

Lynparza (olaparib) is used 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.

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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 of the same.

Currently, Lynparza is the first and only approved medicine targeting BRCA mutations in early-stage breast cancer.

Breast cancer is one of the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed per year.

Early diagnosis and biomarker testing play a critical role in identifying high-risk patients and improving patient outcomes by preventing disease recurrence.

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https://thehealthmaster.com/2022/08/21/dcgi-approves-olaparib-as-monotherapy-for-high-risk-early-breast-cancer/