pharmaand GmbH Receives Positive CHMP Opinion for Rubraca (rucaparib) as a First-Line Maintenance Treatment in Advanced Ovarian Cancer
October 17, 2023 – Pharmaceutical – CHMP, ovarian cancer, pharmaand
- CHMP positive opinion based on the results from Phase 3 ATHENA-MONO trial
- European Commission (EC) approval decision expected in the coming months
- This is the first rucaparibregulatory milestone since being acquired by pharmaand GmbH in May 2023
16 October 2023 — Vienna, Austria — pharmaand (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 European Commission (EC) will review the positive opinion and issue a decision in the coming months. Rucaparib is currently approved as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.
“We are delighted that CHMP has adopted a positive opinion, recommending rucaparib as a first-line maintenance treatment in patients with advanced ovarian cancer who have responded to first-line platinum-based treatment,” said Frank Rotmann, founder and managing director at pharma&. “Today’s positive opinion is a significant milestone in pharma&’s commitment to ensuring enduring availability to essential medicines like rucaparib, allowing healthcare providers and patients access to the treatments they rely on.”
“Accessing effective medicines is the primary goal for both healthcare providers and patients, and it can be devastating when these medicines are no longer available,” said Elmar Zagler, founder and managing director at pharma&. “Over the last five years, pharma& has established itself as an agile, fully integrated global company that aspires to breathe new life into proven medicines like rucaparib.”
The CHMP based its positive opinion on the randomised, double-blind, placebo-controlled, phase 3 ATHENA-MONO trial results. As a first-line maintenance treatment in advanced ovarian cancer, rucaparib significantly improved investigator-assessed progression-free survival (PFS) compared with placebo in women, regardless of their BRCA mutation status in each of the populations studied. The safety profile observed in the ATHENA-MONO trial was consistent with both the current US and European labels for rucaparib.
The ATHENA-MONO trial results were presented during the 2022 American Society of Clinical Oncology Annual Meeting and published in tandem in the Journal of Clinical Oncology.
“In the ATHENA-MONO trial, rucaparib prolonged progression-free survival, irrespective of molecular characteristics, and its potential approval by the EMA as a first-line maintenance treatment is an important step forward in this difficult-to-treat population,” said Dr Rebecca Kristeleit, consultant medical oncologist and adjunct reader at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, London, UK, and European Network of Gynaecological Oncological Trial (ENGOT) lead of the ATHENA trial. “Women with advanced ovarian cancer need and deserve new treatment options to improve outcomes, and today’s recommendation is hopeful news for eligible patients in Europe.”
pharma& currently anticipates an EC approval decision in the coming months.
About pharma&
pharmaand (pharma&), a privately owned global company, aspires to breathe new life into proven medicines through an agile and fully integrated business model, guaranteeing the enduring availability, dependability and quality of essential drugs worldwide that patients and healthcare providers rely on. Over the past five years, pharma& has acquired and integrated 11 medicines, expanding its portfolio across a wide range of therapy areas, with an increasing focus on haematology and oncology treatments. The company’s unique synthesis of subsidiaries, joint ventures and partners enables pharma& to provide its portfolio of medicines to eligible patients worldwide by spanning the continuum of manufacturing, distribution, healthcare providers, administration/access and patient support.
pharma& holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside the US, Europe and Israel. Visit: www.pharmaand.com.
