FDA approves ovarian cancer drug
WASHINGTON — Tesaro on Monday announced the Food and Drug Administration approved Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. According to Tesaro, an oncology-focused biopharmaceutical company, Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing.
Tesaro expects to launch Zejula in the United States in late April.
"We are so gratified to bring this unique new medicine to women with ovarian cancer, and would like to thank the patients who gave selflessly to participate in this trial with the assistance of their caregivers and physicians. We consider clinical trial participants to be the most important contributors to the success of the Zejula clinical development program," said Mary Lynne Hedley, Ph.D., President and COO of Tesaro. "We would also like to express our appreciation to the FDA for its rapid and thorough assessment of the Zejula application in less than three months after it was accepted for review, as well as our partners at Engot for their diligence and care in executing the Nova clinical trial. Tesaro is committed to supporting women bravely facing ovarian cancer and we are planning to work with patients, healthcare providers and payers to ensure access to this paradigm-changing medicine."