Clinigen partners with Tesaro’s PARP med for European preapproval access

Zejula was approved by the FDA earlier this year, with Clinigen also running a managed access program for Tesaro in the U.S.

CRO Clinigen is teaming up with biotech Tesaro and its PARP ovarian cancer med niraparib to help launch an early access program in Europe, coming after the pair joined forces for the same program in the U.S.

The drug in fact gained approval in the U.S. just two months ago under the brand name Zejula, specifically for women with recurrent ovarian, fallopian tube or peritoneal cancer who’ve previously responded to platinum chemo.

It is still awaiting an EU decision on the med, and the tie-up helps offer the drug to recurrent ovarian cancer patients before it gains a final nod across the continent. It was submitted for EMA review in October last year.

Both Clinigen and Tesaro have already worked together for the med in the U.S., where the managed access program allowed doctors to request niraparib for individual, eligible American patients who couldn’t be in trial for the drug, nor have any other treatment option, but could be helped by the therapy before its approval.

This also comes just a few weeks after Clinigen scored a similar pact with French pharma Onxeo to bring blood cancer med belinostat to European patients, again through a managed access program and before its approval.

In this program, the CRO’s support to doctors include screening, drug supply, customer service, and appropriate regulatory documents.

Steve Glass, chief commercial officer of the North America and Europe unit of Clinigen, said: “Following the successful delivery of the niraparib managed access program in the U.S., we are pleased to be partnering with Tesaro once again, providing eligible women in Europe the opportunity to gain access to this important investigational therapy.”

Martin Huber, M.D., SVP and chief medical officer of Tesaro, added: “We are proud to partner with Clinigen on this important managed access program for women bravely facing ovarian cancer. The team at Clinigen has proven to be a partner of choice for Tesaro as we look to address the needs of the ovarian cancer community.”