Armed with fast-track status from the FDA, Waltham, MA-based Tesaro $TSRO has got the ball rolling on its closely-watched regulatory filing for niraparib, one of the leading PARP inhibitors in late-stage development. The biotech has begun a rolling submission at the FDA for its drug as several competitors line up to vie for the lead.
The next big step at Tesaro will be outlining the data from the Phase III study of this drug. And what we know so far is promising.
For patients who were not germline BRCA mutation carriers but whose tumors were determined to be HRD positive, Tesaro reported, the niraparib arm hit the primary endpoint with a median PFS of 12.9 months compared to 3.8 months for the control arm. And in the overall non-germline BRCA mutant cohort, which included patients with both HRD-positive and HRD-negative tumors, the PFS was 9.3 months for niraparib compared to 3.9 months for control.
Provided that all holds up under scrutiny, Tesaro will be angling to complete its filing with the FDA before the end of 2016, with a hoped-for approval next year. They’ll be looking to beat Pfizer $PFE now, which is picking up talazoparib in its $14 billion Medivation buyout. AstraZeneca $AZN managed to beat out a negative panel vote — the data were messy — to make it to the market first with Lynparza (olaparib), but now they’re coming back with Phase III data that may make a big difference on the competitive front.
Clovis $CLVS, meanwhile, is in hot pursuit of a badly needed thumbs-up for rucaparib. Just days ago the FDA waved a panel review for the PARP inhibitor, leading quite a few analysts to conclude that the company was being positioned for a likely approval. And then AbbVie is somewhere in the mix with its own drug, velaparib (ABT-888).
Tesaro’s EMA application is slated to arrive in the fourth quarter.
Lynparza is priced at $12,000 a month, which tends to spur criticism over the high price of drugs relative to their benefits.
“The quality of data” backing PARP inhibitors “has been fairly weak and rather unimpressive,” Vinay Prasad, an oncologist who studies clinical trial design, told the Wall Street Journal a few days ago. A spokesperson for AstraZeneca, meanwhile, told the Journal that their new data will be available later this year, which may help answer its critics. They’ll need something much better than what they have to stave off the oncoming competition.
“We look forward to presentation of data from the Phase 3 NOVA trial of niraparib in a Presidential Symposium session at the European Society for Medical Oncology (ESMO) congress on October 8,” noted Tesaro President Mary Lynne Hedley.
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