FDA approves Zejula for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers.
Today, the FDA approved niraparib (Zejula) for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers who have completely or partially responded to platinum-based chemotherapy, according to a press release.
“Despite high response rates to platinum-based treatment in recurrent ovarian cancer patients, the effectiveness of such chemotherapy diminishes over time. Unfortunately, progression free survival generally gets shorter after each subsequent treatment with a platinum-based chemotherapy regimen. Therefore, a treatment like Zejula that can increase progression-free survival after platinum therapy is very meaningful to patients and their families,” said Ursula Matulonis, MD, in a press release. “Until recently, there have been few treatment advances for women with recurrent ovarian cancer and even fewer options available for women who do not harbor BRCA mutations. We are excited to have the opportunity to offer appropriate patients an oral, once-daily maintenance treatment that reduces the risk of cancer progression and extends the time between courses of chemotherapy for patients who have few treatment options.”
The approval was based on the NOVA clinical trial, which included 553 patients with the cancers who had received 2 or more treatments with platinum-based chemotherapy. All patients included were in complete or partial response to the treatment.
Within 8 weeks of their last chemotherapy session, patients were randomized to receive either niraparib (300-mg per day) or placebo.
Patients were assigned to groups based on BRACAnalysis CDx. There were 203 patients with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut) assigned to the gBRCAmut cohort, while 350 patients were assigned to the non- gBRCAmut cohort, according to the FDA.
The investigators found that patients treated with niraparib had a statistically significant improvement in progression-free survival (PFS) compared with placebo. Median PFS for patients taking niraparib without the mutation was 9.3 months, compared with 3.9 months for patients in the non-gBRCAmut cohort taking placebo.
The safety of niraparib was assessed in 367 patients with recurrent ovarian, fallopian tube, and primary peritoneal cancer. Common adverse reactions included thrombocytopenia; anemia; neutropenia; leukopenia; palpations; nausea; constipation; vomiting; abdominal pain/distention; mucositis/stomatitis; diarrhea; dyspepsia; dry mouth; fatigue; decreased appetite; urinary tract infection; AST/ALT elevation; myalgia; back pain; arthralgia; headache; dizziness; dysgeusia; insomnia; anxiety; nasopharyngitis; dyspnea; cough; rash; and hypertension, the FDA reported.
Approximately 1.4% of patients also experienced myelodysplastic syndrome or acute myeloid leukemia, sometimes occurring simultaneously, while 1.1% of placebo patients developed the conditions.
Niraparib has been approved in a dose of 300-mg once daily, taken with or without food, the FDA concluded.
Niraparib was previously granted fast track designation in September 2016 by the FDA, and was granted priority review in December 2016. The drug is also being tested across multiple tumor types, as well as in various combinations.
“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, PhD, president and chief operating officer 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.”