INDIA- Pharmaceutical company AstraZeneca India has received the go-ahead to market its breast cancer medicine by the Drugs Controller General of India (DCGI).
The DCGI has cleared Lynparza (Olaparib) as a monotherapy in adults with early breast cancer who have previously received neoadjuvant or adjuvant chemotherapy.
According to a statement from AstraZeneca India, the clearance was based on findings from the OlympiA Phase III trial that found Olaparib showed a statistically significant and clinically significant improvement, with a benefit to overall survival.
“The regulatory approval of Lynparza reinforces our growing capabilities in innovation and clinical research for providing holistic solutions for cancer treatment in India,” AstraZeneca India Managing Director and Country President Gagandeep Singh noted.
Lynparza is now licensed for the treatment of early-stage breast cancer in the US, EU, Japan, India, and a number of other nations owing to the DCGI’s approval.
It is the first FDA-approved drug that specifically targets BRCA (Breast Cancer gene) mutations in early-stage breast cancer.
Breast cancer has ranked number one cancer among Indian females with age adjusted rate as high as 25.8 per 100,000 women and a mortality of 12.7 per 100,000 women.
Breast cancer is not an infectious or transmittable illness. There is no known link between the development of breast cancer and any known viral or bacterial infections.
This contrasts with several cancers that have infection-related origins, such as human papillomavirus (HPV) infection and cervical cancer.
The female gender and age are the only known risk factors for breast cancer in almost half of the women who acquire the disease.
In 2020, 685 000 people worldwide died and 2.3 million women were diagnosed with breast cancer.
Breast cancer has ranked number one cancer among Indian females with age adjusted rate as high as 25.8 per 100,000 women and a mortality of 12.7 per 100,000 women.
World Health Organization had estimated Breast Cancer to be the most common cancer in the world by the end of 2020 when 7.8 million women had received a diagnosis within the previous five years.
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