Zejula (niraparib)

PARP inhibitor (olaparib and niraparib) maintenance therapy yields favorable clinical outcomes for elderly ovarian cancer patients. Three clinical factors, attainment R0(no residual disease) after initial surgery, BRCA mutation, and CA-125 ≤10 U/mL before PARP inhibitor treatment, were predictive of longer PFS in elderly ovarian cancer patients undergoing first-line maintenance therapy with PARP inhibitors.

Agents such as olaparib, talazoparib, and niraparib have demonstrated promising efficacy in both neoadjuvant and adjuvant settings with some trials suggesting that selected patients may avoid chemotherapy. Overall, current evidence supports the role of HRD as a promising biomarker in TNBC. However, further research is required to refine its clinical utility and to integrate HRD testing into personalized treatment strategies, especially in combination with emerging therapies such as immunotherapy.

P2, N=200, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028

P2, N=51, Active, not recruiting, University Health Network, Toronto | Trial completion date: Dec 2025 --> Dec 2026

P1, N=31, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Jun 2026 | Trial primary completion date: Dec 2026 --> Jun 2026

Niraparib exhibits antitumor effects and promotes ferroptosis by inhibiting TM4SF1 expression through ALKBH1-mediated 6mA modification in BRCAwt OC. These findings emphasize the potential application of niraparib in BRCAwt OC and reveal the important role of epigenetic regulation in cancer treatment.

Calibration curves proved linear over the studied range, confirming the method's reliability. The results indicate that this stability-indicating approach is highly effective for routine in-process quality control, batch release testing, and long-term stability monitoring of niraparib drug substances.

One patient had a single brain metastasis and received comprehensive treatment including surgery, radiotherapy, chemotherapy, PD-1 inhibitor (tislelizumab), and PARP inhibitor (niraparib). The immune microenvironment characteristics of brain metastases (e.g., high PD-L1 expression, T-cell infiltration) may predict the efficacy of immunotherapy, but the prognosis for patients with multiple brain metastases remains poor. Further research is needed to explore the correlation between peripheral blood immune markers and treatment response in brain metastases.

High-level evidence, including prospective interventional studies, supports exposure-guided dosing for imatinib and sunitinib, demonstrating improved molecular or clinical outcomes when predefined trough concentration targets are achieved. For alectinib, cabozantinib, trametinib, and lenvatinib, consistent exposure-response or exposure-toxicity relationships and pragmatic concentration thresholds support selective implementation, although randomized validation remains limited. For agents such as osimertinib, brigatinib, olaparib, and niraparib, monitoring appears most clinically relevant in toxicity-driven scenarios rather than for efficacy optimization. In contrast, lorlatinib currently lacks a clearly defined therapeutic window, limiting routine applicability...In conclusion, therapeutic drug monitoring and model-informed precision dosing are ready for selective clinical adoption in a subset of oral targeted therapies. Future prospective trials integrating pharmacometric tools with patient-centered outcomes are required to refine exposure targets and expand evidence-based implementation.

Complete remission was obtained using stereotactic radiotherapy to the brain lesions, followed by platinum-based chemotherapy and maintenance therapy with bevacizumab and olaparib...Their role in this setting remains emerging and primarily supported by limited case reports and small series. Further studies are required to better define their role.

These data demonstrate clinical activity of niraparib in patients with metastatic or unresectable pancreatic cancers harboring DDR gene defects. Future studies are warranted to establish their roles in diverse genetic patient subpopulations.

P1/2, N=34, Active, not recruiting, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2027 --> Mar 2027