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AstraZeneca receives marketing permission for Olaparib tablet

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Olaparib (Lynparza) tablet will be used for treating ovarian and breast cancer in India

AstraZeneca Pharma India (AZPIL) recently announced that it has received Import & Market permission for olaparib (Lynparza)100 mg and 150 mg tablets in India by the Drug Controller General of India (DCGI). The receipt of this permission paves way for the launch of olaparib (Lynparza) in India, subject to the receipt of further related statutory approvals and licenses.

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.

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. Olaparib (Lynparza) is a patented product of the AstraZeneca group.

Gagan Singh, Managing Director, AstraZeneca Pharma India 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 has historically been difficulty-to-treat diseases. Today’s approval will bring this innovative, targeted option that may help to delay disease progression for these patients.”

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