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DCGI approves AstraZeneca India’s breast cancer drug

Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer 

AstraZeneca India has received 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.

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.

Speaking on this, Gagandeep Singh, MD and Country President, AstraZeneca India, said, “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.”

Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said “The marketing approval for Lynparza presents the early-stage BRCA mutated breast cancer patients in India with a new targeted therapy option. It reduces the risk of disease recurrence in these high-risk patients, and now the new data from OlympiA Phase III trial also confirms that it significantly extends the lives of the patients. The approval will provide Oncologists with a potential therapeutic option to be given with curative intent to eligible early breast cancer patients.”

The results from the landmark OlympiA Phase III trial highlight the value and importance of testing for BRCA mutations at diagnosis. Olaparib demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death by 42 per cent versus placebo. The newly updated results from the OlympiA trial also showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS), reducing the risk of death by 32% versus placebo.

“Our role here is to focus on improving access to this futuristic bedrock of precision treatment that has the potential to save lives. The clinical strategy aims to transform survival by seeking to combat metastatic and resistant diseases and providing options to treat early. Our oncology portfolio has been consistently growing in the range of 40 per cent to 50 per cent over the last three years. In the year 2021, we registered a growth of 46 per cent in oncology. At AstraZeneca, we see huge potential in the utilisation of cancer related drugs for wider scope,” Gagandeep Singh added.

 

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