The PARP inhibitor niraparib (Zejula) is now available on the PBS for the treatment of women with newly diagnosed advanced ovarian cancer who have a BRCA mutation.
The drug, imported by GSK, comes as 100mg capsules and appears on the PBS general schedule under streamlined authority from Thursday 1 September.
Its listing this week follows approval by the TGA in November 2021 for the maintenance treatment of all women with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer who respond to first-line platinum-based chemotherapy.
At the time, it was the only PARP inhibitor approved for all women regardless of their BRCA mutational status.
However, at its March 2022 meeting, the PBAC recommended restricting it to those with BRCA1/2 pathogenic gene variants on the grounds of a relatively small (3.5 months) progression-free survival benefit outside that population.
As a result, it was possible there would be no overall survival benefit, as well as added toxicity, the PBAC found.
Two previous applications for funding, in March and July 2021, had been rejected by the PBAC on cost and efficacy grounds.
Nevertheless, gynaecological oncologist Professor Martin Oehler welcomed the subsidy, saying in a media release for GSK that a key advantage of the drug was its flexibility as a treatment option.
“Zejula allows healthcare professionals to provide women with an individualised dose from the outset, which has been shown to reduce the risk of adverse events compared with a fixed dose approach for everyone,” said Professor Oehler, from Adelaide’s Burnside Hospital.
“We can’t underestimate the importance of maximising quality of life for these women who are managing a difficult disease on top of their existing family and work commitments.”
He added: “Historically ovarian cancer hasn’t received the same attention as other diseases, so having a new treatment option funded by government signals a renewed momentum into the management of this challenging condition.”
The approval was based on results from the Phase III PRIMA trial which demonstrated statistically significant and clinically meaningful progression-free survival with niraparib compared to placebo in all participants (HR 0.62; p<0.0001) and in a homologous recombination deficient sub group (HR 0.43, p<0.0001).
Separately, the PBAC has recently recommended PBS listing of atezolizumab for the adjuvant treatment of patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumours have PD-L1 expression on ≥ 50% of tumour cells and following a complete resection and no progression after platinum-based adjuvant chemotherapy.
At its July 2022 meeting, it also recommended the addition of 400 mg Q6W pembrolizumab dosing regimen for all existing and recommended pembrolizumab PBS listings.