Conduct Phase III CT : CDSCO panel tells AstraZeneca for anticancer drug Olaparib Film coated Tablet

Written by Dr. Divya Colin Published On 2023-03-17T18:00:11+05:30 | Updated On 17 March 2023 6:00 PM IST

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New Delhi: The Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has opined the drug major AstraZeneca to conduct the Phase III clinical trial of Olaprib film-coated Tablets 100mg/150mg for the additional indication as in combination with Abiraterone and Prednisone or Prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer.

This came after the firm presented the proposal for import and marketing of the drug Olaparib film-coated Tablets 100mg/150mg for the additional indication as “In Combination with Abiraterone and Prednisone or Prednisolone is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer” along with clinical trial waiver justification and some global clinical trial data, before the committee.

Olaparib belongs to a class of drugs called Antineoplastics, PARP Inhibitors. Olaparibis indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Olaparib inhibits poly(ADP‐ribose) polymerase, thereby blocking the repair of single‐strand DNA breaks. This results in synthetic lethality in BRCA‐associated cancer cells, which have a dysfunction of another DNA repair pathway – homologous recombination.

At the recent SEC meeting for Oncology and Hematology held on 23rd of February 2023, the expert panel reviewed the proposal presented by the drug major AstraZeneca for importing & marketing of the drug Olaparib film-coated Tablets 100mg/150mg for an additional indication as “In Combination with Abiraterone and Prednisone or Prednisolone is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer”alongwith CT waiver justification and some global clinical trial data.

The committee noted, "The firm was shown Phase IV/ PMS data in Indian patients for the drug product and presented some Global clinical trial data of Olaparib conducted in other countries with respect to the proposed indication."

In addition, the committee also noted that India was not part of these global clinical trials.

In the view above, the committee recommended,

"The firm should conduct a Phase III clinical trial for the proposed indication. The firm should submit Phase III clinical trial protocol for further review by the committee."

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.