AstraZeneca Olaparib gets CDSCO Panel okay for BRCA mutated HER2 negative breast cancer
New Delhi: Based on the scientific data provided by the drug maker AstraZeneca, the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) has given its nod for the additional indication of the anticancer Drug Olaparib film coated tablet 100/150 mg for breast cancer with adult patients with BRCA-mutated HaeR2- negative.
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 the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) had rejected the proposal to import and market the antineoplastic drug Olaparib film-coated tablets 100 mg and 150 mg.
In addition, the expert panel 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.
Furthermore, the committee noted the interim results of the ongoing Phase IV clinical trial of Olaparib Film Coated Tablet 100/150 mg.
