DCGI approves AstraZeneca’s Lynparza as a monotherapy for high-risk early breast cancer

Bengaluru: AstraZeneca India, a leading science-led biopharmaceutical company, has announced that it has received a 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, Managing Director 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.” 

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 plays a critical role in identifying high risk patients and improving patient outcomes by preventing disease recurrence. Early breast cancer is defined as the cancer confined to the breast with or without regional lymph node involvement and the absence of distant metastatic disease.

The results from the landmark OlympiA Phase III trial, highlights 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% versus placebo. New 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.

Non-Communicable Diseases (NCDs) like cancer in India today account for 62% of all deaths and 48% of preventable premature deaths. Moving on from the Covid-19 pandemic, AstraZeneca aims to address the larger burden of NCDs on the healthcare systems and focus on therapies for serious ailments like cancer.

“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 disease and providing options to treat early. Our oncology portfolio has been consistently growing in the range of 40% to 50% over the last 3 years. In the year 2021, we registered a growth of 46% in oncology. At AstraZeneca, we see huge potential in the utilization of cancer related drugs for wider scope,” Gagandeep Singh added.