Setback: AstraZeneca proposal to market, manufacture Olaparib rejected by CDSCO panel
New Delhi: In a major setback to AstraZeneca, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has rejected the proposal to import and market the antineoplastic drug Olaparib film-coated tablets 100 mg and 150 mg.
This came in line with the proposal presented by pharma major AstraZeneca Pharma to manufacture and market the anticancer drug Olaparib film-coated tablets 100 mg and 150 mg (Additional Indication) for monotherapy or 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.
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor used to treat ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. PARP inhibitors constitute a class of anti-cancer therapy. They work by taking advantage of a defect in DNA repair in cancer cells with BRCA( breast cancer gene) mutations and inducing cell death.
Olaparib is a cytotoxic and anti-tumor agent.PARPs recognize and repair cellular DNA damage, such as single-strand breaks (SSBs) and double-strand breaks (DSBs). It can act as a chemosensitizer to potentiate the cytotoxicity of DNA-damaging chemotherapeutic agents such as alkylating agents and platinum-based drugs.
Earlier the Medical Dialogues Team had reported that AstraZeneca Pharma India Limited had received Import and Market permission in Form CT-20 (Marketing Authorization) from the Drugs Controller General of India for Olaparib Film-Coated tablets 100 mg and 150 mg - additional indication.
At the recent SEC meeting for Oncology and Hematology held on 12th April 2022, the expert panel reviewed the proposal to manufacture and market the anticancer drug Olaparib film-coated tablets 100 mg and 150 mg in detail.
After detailed deliberation, the committee opined that the firm should submit CSR of the ongoing Phase IV clinical trial in an already approved indication (vide permission no. IMP-ND-189/2018 dated 13.08.2018) for taking further action in the matter.
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