Lynparza(olaparib)

Lynparza (olaparib) is an oral medication with a molecular weight of 434.5 g/mole. The recommended dose is 300 mg administered orally twice daily (tablet formulation) or 400 mg orally twice daily (capsule formulation). Regulatory reviews recommended approval for Lynparza, with an ODAC vote of 11-2 for accelerated approval in gBRCAm patients.

In a study involving 796 randomized patients (399 in the olaparib arm, 397 in the placebo arm), Lynparza demonstrated a significant improvement in radiographic progression-free survival (rPFS) in the ITT population, with a Hazard Ratio of 0.66 (95% CI: 0.54, 0.81; p-value <0.0001). The median rPFS for the olaparib arm was 25 months, compared to 17 months for the placebo arm. In the BRCAm subgroup, the Hazard Ratio for rPFS was 0.24 (95% CI: 0.12, 0.46), with a median rPFS of 8 months in the placebo arm. The overall survival Hazard Ratio in the ITT population was 0.81 (95% CI: 0.67, 1.00).

Safety findings indicated that 56% of patients receiving olaparib + abiraterone experienced Grade ≥ 3 adverse reactions, compared to 43% in the abiraterone + placebo group. Adverse events led to discontinuation in 2% of patients, dose interruption in 30% of patients, and dose reduction in 23% of patients.