CDSCO Panel grants AstraZeneca's proposal for withdrawing specific Indications of Olaparib Tablets

New Delhi: Reviewing the Clinical evidence presented by drug major AstraZeneca, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the withdrawal of the indication of Olaparib 100mg and 150mg tablets in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

This came after AstraZeneca presented the clinical evidence for the withdrawal of indication of AstraZeneca's Olaparib 100mg and 150 mg tablets in the treatment of patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor. It works by killing cancer cells.

Olaparib is used alone or in combination with bevacizumab (Avastin) to help maintain the response of certain types of ovarian (female reproductive organs where eggs are formed), fallopian tube (the tube that transports eggs released by the ovaries to the uterus), and peritoneal (layer of tissue that lines the abdomen) cancer in people who have completely responded or partially responded to their first or later chemotherapy treatments. Olaparib is also used to treat certain types of breast cancer that have spread to other parts of the body and have not improved or have worsened after treatment with other therapies. It is also used to treat certain types of early breast cancer in people who have already been treated with surgery and other chemotherapy treatments.

Olaparib is also used to treat a certain type of prostate cancer that has spread to other parts of the body, no longer responds to medical or surgical treatments to lower testosterone levels, and has progressed after treatment with enzalutamide (Xtandi) or abiraterone (Yonsa, Zytiga). It is also used in combination with abiraterone and prednisone to treat a certain type of prostate cancer that has spread to other parts of the body and no longer responds to medical or surgical treatments to lower testosterone levels.

Olaparib is also used to help maintain the response of a certain type of pancreatic cancer that has not spread or progressed after the first chemotherapy treatment.

At the recent SEC meeting for Oncology held on 19th & 20th March 2024, the expert panel reviewed the proposal presented by drug major AstraZeneca for the withdrawal of indication of the drug Olaparib 100mg and 150mg tablets in the treatment of the patients with gBRCA mutation and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

After detailed deliberation, the Subject Expert Committee has agreed to withdrawal the same indication.

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