Zejula Approved for Recurring Ovarian Cancer Treatment
March 27, 2017 – The U.S. FDA granted priority-review approval for Zejula™ (niraparib), manufactured by Tesaro, Inc. It is indicated for maintenance treatment of women who have responded at least partially to platinum-based chemotherapy for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Although it is a poly ADP-ribose polymerase (PARP) inhibitor, Zejula does not require testing for a biomarker, such as BRCA gene mutations, like other PARP inhibitors do. Recommended dosing is 300mg (three capsules) orally once a day until the cancer worsens or side effects are unbearable. Launch is planned for late in April and cost will not be disclosed until then. Distribution will be through a limited network.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.