AstraZeneca Pharma India Ltd (AZPIL) announced today that it has received import and market permission for Olaparib (Lynparza) 100 mg and 150 mg tablets in India from the Drug Controller General of India (DCGI). The receipt of this permission paves the way for the launch of the drug in India, subject to the receipt of further related statutory approvals and licenses.

Olaparib is the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor and the first targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as BRCA mutations, to preferentially kill cancer cells.

For ovarian cancer, olaparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. It is also indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.

As there is no cure for relapsed ovarian cancer, the primary aim of treatment is to slow progression of the disease for as long as possible and improve or maintain the patient’s quality of life.

For breast cancer, olaparib is indicated for patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer, who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.

While there is currently no cure for metastatic breast cancer, olaparib now offers a new, targeted option that may help to delay disease progression for these patients.

Gagan Singh, Managing Director, AstraZeneca Pharma India Ltd said, “The import and market permission for olaparib is a significant milestone for women in India living with platinum-sensitive relapsed ovarian cancer and BRCA-mutated HER-2 negative metastatic breast cancer, which have historically been difficult-to-treat diseases. The approval will bring this innovative, targeted option that may help to delay disease progression for these patients.”

Breast and ovarian cancers are the leading causes of cancer-related deaths in women of India. According to a three-year report of population-based cancer registries -- 2012-2014 in India, ovarian cancer is the third leading site of cancer among women, trailing behind breast and cervical cancer. The age-adjusted incidence rates of ovarian cancer vary between 1.7 and 15.2 per 100,000 population in different parts of the country.

Ovarian cancer has the worst prognosis among all gynaecological malignancies. The overall five-year survival rate was 46 per cent in the US in 2017, while it was 15·6 per cent during the period 2010-14 in India , primarily due to the late stage of the disease at diagnosis.

Breast cancer has been ranked the number one cancer among Indian females, with the age adjusted rate ranging from 4.4 to 41.0 per 100,000 women . Mortality-to-incidence ratio for breast cancer was found to be as high as 0.66 in rural registries, whereas it was as low as 0.08 in urban registries. It is projected that 56,276 and 1,79,790 Indian patients would suffer from ovarian cancer and breast cancer, respectively, in 2020. In India, the five-year survival rate for patients with breast cancer is 66·1 per cent during the period 2010-14. Most Indian studies have showed an inverse relationship of stage of disease with survival. Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and difficult to treat.

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