Call it an early spring surprise for Tesaro. The company’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod Monday, months before its scheduled decision date.
And not only that. Zejula won an approval that’s broader than the label on its head-to-head rival, Lynparza from AstraZeneca. It’s approved to treat all women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo, not just those who test positive for the BRCA genetic mutation.
With 2022 sales expectations of $1.9 billion, Zejula is one of the top drug launches of 2017, according to EvaluatePharma’s numbers. And with some strong data showing its ability to hold off cancer progression for more than a year in some patients, it could be a quick challenger for market share when it launches, expected in late April.
Zejula is a PARP inhibitor, a class that now includes AZ’s Lynparza—the first-to-market med, which racked up some impressive survival data of its own earlier this month—and Clovis Oncology’s Rubraca, approved late last year. Both those meds are also approved to treat recurrent ovarian cancer, but in women with the BRCA mutation who've been treated previously with three different chemotherapies, and Rubraca patients have to fail on two other therapies first. Meanwhile, Pfizer is working its way toward a prostate cancer approval for talazoparib, the PARP inhibitor it acquired with Medivation for $14 billion last year.
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In its approval announcement, Tesaro quickly exercised its bragging rights, not just on the broad approval, but on the trial data that supported it. “Zejula is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing,” the company said, adding that it’s also “the only PARP inhibitor that has demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status.”
In trial results unveiled at the European Society for Medical Oncology meeting last fall, the drug delivered a 15.5-month progression-free survival advantage over placebo in BRCA-mutated ovarian cancer, and a 5.4-month advantage in women without the mutation. In a subset of non-BRCA cancers—those that tested positive for a different abnormality—niraparib delayed cancer’s advance by 12.9 months, compared with 3.8 months in the control group, an improvement of more than 9 months.
"We have never seen such large benefits in progression-free survival in recurrent ovarian cancer,” the study's lead author, Mansoor Raza Mirza, M.D., of Copenhagen University, said at the time. “Niraparib significantly improved all endpoints across a broad patient population representing 70% of all ovarian cancer patients.”
Tesaro also said Monday that it plans to expand its research program for niraparib, with combination approaches alongside Roche’s Avastin and a PD-1 immunotherapy, expanded efforts in first-line ovarian cancer, and a move into first-line metastatic non-small cell lung cancer.