GSK gets CDSCO Panel nod to market anticancer Niraparib Tablet

This nod is subjected to the following conditions that the firm should conduct a Phase IV clinical trial in the country for which the protocol should be submitted to CDSCO within two months of the drug's approval for further review by the committee.

This came after the firm presented their proposal for the import and marketing of the drug Niraparib Tablets, 100 mg, along with justification for a local phase III clinical trial waiver.

Niraparib is a poly-ADP ribose polymerase inhibitor used to treat recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer responding to platinum-based chemotherapy.

Earlier, the Medical Dialogues Team had reported that GlaxoSmithKline plc had announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status.

Furthermore, the study showed that until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.

Niraparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, PARP-1 and PARP-2, which play a role in DNA repair.

In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis and cell death. Increased niraparib-induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2. Niraparib decreased tumor growth in mouse xenograft models of human cancer cell lines with deficiencies in BRCA1/2 and in human patient-derived xenograft tumor models with homologous recombination deficiency that had either mutated or wild type BRCA1/2.

At the recent SEC meeting for Oncology & Haematology, the expert panel reviewed the proposal for import and marketing of Niraparib Tablets 100mg along with the justification for a local phase III clinical trial waiver presented by GSK Pharma.

The committee noted that Niraparib tablet formulation is approved in countries including the European Union and Singapore. Furthermore, the expert panel noted that the drug is indicated for a serious and life-threatening disease, and there is an unmet medical need in the country.

After detailed deliberation, the committee recommended the grant of permission to import and market Niraparib Tablets 100 mg, subject to the conditions that the firm should conduct a Phase IV clinical trial in the country for which the protocol should be submitted to CDSCO within two months of approval of the drug for further review by the committee.