FDA approves Tesaro’s Zejula for recurrent ovarian cancer

Zejula is a poly(ADP-ribose) polymerase (PARP) inhibitor which has to be taken orally daily once. It has been approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.

Expected to launch in the US by April end, Zejula is the first PARP inhibitor to have been approved by the regulator that does not require BRCA mutation or other biomarker testing.

FDA’s Oncology Center of Excellence director Richard Pazdur said: “Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment.

“Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.”

The drug’s approval is based on a phase 3 trial where it had shown to have increased the progression-free survival (PFS) meaningfully in women with recurrent ovarian cancer, irrespective of BRCA mutation or biomarker status.

Dubbed as ENGOT-OV16/NOVA, the phase 3 trial was held in multiple centers across the world, featuring 553 recurrent ovarian cancer patients who had achieved either a PR or CR to their last platinum-based chemotherapy.

In patients with germline BRCA mutations, Zejula was found to have cut the risk of disease progression or death by 74%. For patients without germline BRCA mutations, the drug brought down the same by 55%.

Treatment with Zejula reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations.