Shares in Tesaro Inc (NASDAQ:TSRO) edged higher in pre-market trade on Monday after the European Commission granted marketing authorization for its ZEJULA drug in women with recurrent ovarian cancer.
The treatment is the first once-daily, oral PARP 1/2 inhibitor to be approved in Europe that doesn’t require a BRCA mutation or other biomarker testing.
Tesaro said the approval had been supported by “robust data” from a phase III trial which showed Zejula “significantly increased” progression free survival – how long a patient lasts with a disease without it getting worse – compared to the control arm.
“The EC approval of ZEJULA marks TESARO’s second product approval in Europe this year,” said Tesaro President and chief oerating officer Mary Lynne Hedley.
“We are committed to working with healthcare providers, payers and patient groups to enable access to this paradigm-changing treatment as quickly as possible.”
Zejula was approved by the US Food and Drug Administration back in March and is currently marketed in the States by Tesaro where it is the most frequently prescribed PARP inhibitor in ovarian cancer, the company said.
Tesaro said it plans to launch Zejula in the UK and Germany next month, before rolling it out across Europe starting in January.
The stock was up 0.6% to US$86.40 in pre-market trade on Monday.