Currently Viewing
Maintenance Rubraca Granted Priority Review for Ovarian Cancer
December 06, 2017 – Jason M. Broderick
FDA Fully Approves Avastin for Glioblastoma Treatment
December 06, 2017 – Jason M. Broderick
Addressing Survivorship in Cancer Care
December 05, 2017 – Mindy Waizer
Patients Turn to the Internet for Information, But Not Decision-Making
December 05, 2017 – Brielle Urciuoli
Longer Time Between Pre- And Postoperative Chemo Worsens Survival in Ovarian Cancer
December 05, 2017 – Jason Harris
What Comes Next for Cancer Survivors?
December 04, 2017 – Mindy Waizer
Treatment Options Expanding in HER2-Positive Breast Cancer
December 03, 2017 – Angelica Welch
Cannabis Oil Use: Growing Phenom Appears Safe, Helpful in Brain Cancer
December 01, 2017 – Beth Fand Incollingo
FDA Approves Biosimilar for Breast, Stomach Cancer Subtypes
December 01, 2017 – Jason M Broderick

Maintenance Rubraca Granted Priority Review for Ovarian Cancer

A supplemental new drug application (sNDA) for Rubraca (rucaparib), a PARP inhibitor, has been granted a priority review by the Food and Drug Administration.

 
BY Jason M. Broderick
PUBLISHED December 06, 2017
A supplemental new drug application (sNDA) for Rubraca (rucaparib), a  poly (ADP-ribose) polymerase (PARP) inhibitor, to be used as a maintenance treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, has been granted a priority review by the Food and Drug Administration (FDA), according to manufacturer Clovis Oncology.

The sNDA is based on findings from the phase 3 ARIEL3 trial, in which maintenance Rubraca improved median progression-free survival (PFS) by 11.2 months compared with placebo for patients with BRCA-mutant platinum-sensitive ovarian cancer.

For patients with germline or somatic BRCA mutations, there was a 77 percent reduction in the risk of progression or death with Rubraca versus placebo. Moreover, the median PFS with Rubraca was 16.6 months compared with 5.4 months for placebo. Similar PFS benefits were observed in patients with BRCA wild-type tumors and those with homologous recombination deficiency (HRD) or low to high loss of heterozygosity (LOH).

Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision on the sNDA by April 6, 2018.

“We are pleased that we continue to make significant progress toward our goal of delivering rucaparib to a much broader population of women with advanced ovarian cancer,” Patrick J. Mahaffy, President and CEO of Clovis Oncology, said in a press release. “We are particularly encouraged by the FDA’s decision to grant priority review to the application, which may allow us to make Rubraca available to these women in a more expeditious manner.”

Rubraca was initially approved by the FDA in December 2016 as a monotherapy for patients with ovarian cancer with a deleterious BRCA mutation following prior treatment with two or more chemotherapies.
 
Be the first to discuss this article on CURE's forum. >>
Talk about this article with other patients, caregivers, and advocates in the Ovarian Cancer CURE discussion group.

Related Articles

1
×

Sign In

Not a member? Sign up now!
×

Sign Up

Are you a member? Please Log In