Quote this publication Share Print

RUBRACA

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Mar 04 2020

Reason for request

Inclusion

Substantial clinical benefit and minor clinical added value in the maintenance treatment of patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Insufficient clinical benefit to justify reimbursement in the third or later-line treatment of patients with platinum-sensitive, relapsed or progressive, BRCA mutated, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are unable to tolerate further platinum-based chemotherapy.

  • RUBRACA has an MA as monotherapy in high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer: for the maintenance treatment of patients with platinum-sensitive relapsed cancer who are in response (complete or partial) to platinum-based chemotherapy, and also for third or later-line treatment of patients with BRCA mutated cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy.
  • Its superiority over placebo has been established on survival-free progression in maintenance treatment from the second line of treatment, regardless of BRCA mutation status.
  • RUBRACA has no role in the care pathway for third or later-line treatment in BRCA-mutated patients.

Clinical Benefit

Substantial

-

Insufficient

Clinical Added Value

minor

-


Contact Us

Évaluation des médicaments