pharmaand GmbH (pharma&) announced...that the European Commission (EC) has granted marketing authorization for a Type II variation for Rubraca (rucaparib) as a first-line maintenance treatment for all women with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the maintenance treatment of adult 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.

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated...for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Acceptable Recurrence Therapies for Epithelial Ovarian (including LCOC) /Fallopian Tube/Primary Peritoneal Cancer...Recurrence Therapy for Platinum-Sensitive Disease...Preferred Regimens…targeted Therapy (single agents)…Rucaparib

pharmaand GmbH (pharma&) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of a Type II variation for Rubraca® (rucaparib), as a first-line maintenance treatment for all women with advanced ovarian cancer regardless of their BRCA mutation status, who have responded to first-line platinum-based chemotherapy...The CHMP based its positive opinion on the randomized, double-blind, placebocontrolled, Phase 3 ATHENA-MONO trial results.