Niraparib Receives FDA Fast Track Designation for the Treatment of Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Initiation of rolling New Drug Application submission

On 12 September, 2016 TESARO, Inc. an oncology-focused biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to niraparib for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

TESARO has initiated a rolling submission of a New Drug Application (NDA) for niraparib to the FDA, and intends to complete this submission during the fourth quarter.

The Marketing Authorization Application (MAA) for niraparib is planned for submission to the European Medicines Agency in the fourth quarter.

The FDA Fast Track designation is designed to facilitate the development and expedite the review of medicines that are intended to treat serious conditions and address unmet medical needs. As part of the Fast Track programme, the FDA allows for the submission of completed portions of an NDA on an ongoing or rolling basis.

The data from the phase III NOVA trial of niraparib will be presented in a Presidential Symposium session at the ESMO 2016 Congress in Copenhagen.

NOVA is a double-blind, placebo-controlled, international phase III trial of niraparib that enrolled more than 500 patients with recurrent ovarian cancer who were in a response to their most recent platinum-based chemotherapy.

Niraparib is an oral PARP inhibitor that is currently being evaluated in four ongoing pivotal trials.

TESARO is building a robust niraparib franchise by assessing activity across multiple tumour types and by evaluating several potential combinations of niraparib with other therapeutics.

The ongoing development programme for niraparib includes:

  • a phase III trial in patients with platinum-sensitive, recurrent ovarian cancer (the NOVA trial);
  • a phase III trial in patients with first-line ovarian cancer (the PRIMA trial);
  • a registrational phase II treatment trial in patients with ovarian cancer (the QUADRA trial);
  • a phase III trial for the treatment of patients with BRCA-positive breast cancer (the BRAVO trial).

Several combination studies are also underway, including trials of niraparib plus pembrolizumab and bevacizumab.

Niraparib is an investigational agent and, as such, has not been approved by any regulatory agency.

PARP inhibitors are a class of drugs with turbulent history. Companies first started working on PARP inhibitors in the 1990s. In 2011, a phase III trial with Sanofi’s iniparib has failed in triple-negative breast cancer, but it was soon discovered that iniparib was not a bona fide PARP inhibitor. AstraZeneca’s olaprib is first in the class of PARP inhibitors that was approved for medical use.