PARP inhibitor 'Lynparza' reattempts prostate cancer reimb

Two indications, including BRCA mutation, are expected to be considered for the Cancer Disease Review Committee

Failed to be considered for DREC review in 2022…whether Lynparz will be approved for expanded reimbursement garners attention

Product photo of Lynparza

Attention is focused on whether there will be progress in the expanded reimbursement of the PARP inhibitor 'Lynparza' for prostate cancer.

 

According to industry sources, AstraZeneca Korea's PARP (Poly ADP-ribose polymerase) inhibitor Lynparza (olaparib) is expected to be considered for the Health Insurance Review & Assessment Service (HIRA)'s Cancer Disease Review Committee next month (September).

 

The indications for review are two: ▲Treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression after treatment with a novel hormonal agent ▲Combination therapy with abiraterone and prednisolone in adult patients with newly diagnosed mCRPC who have not received prior chemotherapy.

 

This is Lynparza's second attempt to get reimbursement for its prostate cancer indication.

 

AstraZeneca had previously tried in 2022 to get reimbursement for BRCA-mutated prostate cancer, but the application was withdrawn after failing to reach an agreement during the post-Cancer Disease Review Committee procedure.

 

Therefore, it remains to be seen if this second round of reimbursement discussions will be successful.

 

Meanwhile, the efficacy of Lynparza in prostate cancer has been proven through two Phase 3 trials: the PROfound study and the PROpel study.

 

A subgroup analysis of the PROfound study in mCRPC patients with BRCA1/2 mutations showed that in patients who had progressed after prior abiraterone or Xtandi (enzalutamide) treatment, Lynparza significantly improved radiographic progression-free survival (rPFS) to a median of 9.8 months, compared to 3.0 months for the control group.

 

Overall survival (OS) was also improved, with a median of 20.1 months versus 14.4 months for the control group.

 

The PROpel study evaluated the combination therapy of Lynparza and abiraterone in mCRPC patients who had not received prior chemotherapy.

 

The study showed that the combination therapy reduced disease progression or the risk of death by 34% compared to abiraterone monotherapy.

 

The median rPFS was extended by 8.2 months in the combination group, reaching 24.8 months compared to 16.6 months in the abiraterone monotherapy group.