“The introductions of Zejula in Germany and the UK are significant milestones for TESARO as we bring transformative therapies to patients with cancer around the globe,” Orlando Oliveira, senior vice president and general manager of Tesaro International, said in a press release. “With two approved products in Europe, we are working quickly to make our medicines available in the 17 European countries where we have a direct presence.”
In November, the European Commission approved Zejula as a monotherapy to be included in the maintenance treatment of patients with cancer recurrence but who are now in complete or partial response after treatment with platinum-based chemotherapy. The target patients include those with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
Zejula is the first oral PARP inhibitor approved as a treatment in Europe that is available regardless of the mutational status of the BRCA gene or the presence of other specific biomarkers. The therapy eliminates cancer cells by impairing their ability to repairing their DNA.
The treatment was approved in the U.S. for recurrent ovarian cancer patients in March 2017.
Zejula’s approvals were based on the results of the international Phase 3 ENGOT-OV16/NOVA trial (NCT01847274). The study enrolled 553 patients with recurrent ovarian cancer who showed either a partial or complete response to platinum-based chemotherapy. The majority of the patients, around 67 percent, had no inherited BRCA mutations.
Patients were randomized to Zejula or a placebo control (in a 2:1 ratio) administered once a day continuously over 28 days. The results showed that Zejula significantly increased progression-free survival compared to placebo, regardless of BRCA mutational status.
The therapy also reduced by 73 percent and 55 percent the risk of disease progression or death in patients with or without BRCA mutations, respectively.
The European Commission approved Zejula as a starting dose of 300 mg once daily, but patients who weigh less than 128 pounds may be considered for a 200 mg dose.
“As we continue to globalize our mission, we remain committed to enabling access to this important therapy for patients who have completed platinum-based chemotherapy and have limited treatment options,” Oliveira said.