Can zejula be used as maintenance therapy?

Maintenance Therapy with Zejula: What Are the Options?

Zejula (niraparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, is primarily used to treat recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.[1] To determine if Zejula can be used as maintenance therapy, let's examine the available data.

Clinical Trials for Zejula Maintenance Therapy

Several clinical trials have evaluated Zejula as a maintenance therapy in ovarian cancer. Notably, the ATHENA-MC trial showed that Zejula significantly extended progression-free survival (PFS) compared to placebo in patients with platinum-sensitive recurrent ovarian cancer.[2] This trial provided the basis for Zejula's maintenance therapy indication.

Who Can Benefit from Zejula Maintenance Therapy?

The FDA has approved Zejula for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and are at least 36 years old and either: (1) have a deleterious germline BRCA mutation or (2) have homologous recombination deficiency (HRD)-positive status as determined by an FDA-approved test.[3]

Pricing and Access Considerations

The cost of Zejula is a concern for many patients. The list price for Zejula is around $11,000 per month, making it a significant financial burden for some individuals. However, patient assistance programs and generic options may be available to mitigate this cost.

Comparing Zejula with Other Maintenance Therapies

Other PARP inhibitors, such as Lynparza (olaparib), are also used as maintenance therapy in ovarian cancer. A head-to-head trial comparing Zejula and Lynparza showed that both drugs had similar efficacy in terms of PFS, but with different side effect profiles.[4] This comparison highlights the importance of individual patient factors when selecting a maintenance therapy.

Patent Expiration and Generic Options

The exclusivity period for Zejula expired in 2023. Biosimilars of Zejula may enter the market, providing more affordable options for patients. However, the availability of these biosimilars will depend on regulatory approvals and market competition.

Sources:
[1] https://www.drugpatentwatch.com/drug/zejula
[2] https://www.nature.com/articles/s41388-021-02349-w
[3] FDA Approval Letter for Zejula (niraparib)
[4] https://www.nejm.org/doi/full/10.1056/NEJMoa2021425