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AstraZeneca India wins DCGI approval to launch a breast cancer medication!

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Mumbai, India (CU)_ According to the latest statement from AstraZeneca India, it has got clearance from the Drugs Controller General of India to launch its breast cancer therapy medication. The pharmaceutical giant expressed delight over the approval of the medication. The Drugs Controller General of India (DCGI) has cleared Lynparza (Olaparib) as a monotherapy for treating adult patients suffering from early breast cancer who have had neoadjuvant or adjuvant chemotherapy.

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According to the statement released by AstraZeneca India, the clearance depended on results from the OlympiA Phase III study, which revealed that Olaparib showed a statistically significant and clinically relevant improvement, along with an overall survival benefit. With the approval from DCGI, Lynparza is now accepted for treating early-stage breast cancer in The United States, the European Union, Japan, India, and other nations.

At present, Lynparza is the only approved medication for treating early-stage BRCA (Breast Cancer gene) mutations in breast cancer. Gagandeep Singh, Managing Director and Country President of AstraZeneca India, expressed hopes for the new medication. He said, “The regulatory approval of Lynparza…reinforces our growing capabilities in innovation and clinical research for providing holistic solutions for cancer treatment in India”.

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Breast cancer is one of the most frequently diagnosed cancers in the world, with an estimated 23 lakh new cases identified every year. In India, Non-Communicable Diseases (NCDs) such as cancer contribute to 62% of the total fatalities and 48% of premature deaths that are avoidable. Singh expressed confidence in the new drug. He stated, “Our oncology portfolio has been consistently growing in the range of 40 to 50 percent over the last 3 years. At AstraZeneca, we see huge potential in the utilization of cancer-related drugs for wider scope”.

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