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Pharmaand GmbH announced today that the UK's National Institute of Health and Care Excellence (NICE) has published on February 19 the Final Draft Guidance recommending the use of rucaparib in England, Wales and Northern Ireland as an option for the maintenance treatment of advanced high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer.
This is after complete or partial response to first-line platinum-based chemotherapy in adults, only if: it is BRCA mutation-negative and homologous recombination deficiency (HRD)-positive, or it is BRCA mutation- negative, and HRD status is negative or unknown, and bevacizumab is not a treatment option because NHS England’s BEV3 and BEV10 commissioning approval criteria for having it are not met, or it is contraindicated or not tolerated.1
“Today’s decision marks a significant step forward for women with advanced ovarian cancer in England, Wales and Northern Ireland,” said Frank Rotmann, Founder and Managing Director, pharma&.
“We are committed to ensuring that all eligible patients are able to access and to potentially benefit from rucaparib.” Currently, only one in three women diagnosed with ovarian cancer in the United Kingdom (UK) survive their disease for 10 years or more.2
Ovarian cancer is the sixth most common cause of cancer-related death among women in the UK.2
Between 2017-2019, Cancer Research UK estimated that over 7,500 women received a new diagnosis of ovarian cancer2, with more than 75% of women diagnosed at an advanced stage.3
“The availability of rucaparib for eligible BRCA-mutation negative patients is a significant milestone and provides an additional treatment option that has been shown to improve progression-free survival and reduce the risk of disease progression,” said Prof. Iain McNeish, Imperial College London, London, UK.
“This decision represents an advance in our ongoing effort to improve outcomes for patients facing advanced ovarian cancer.”
“Ovacome is delighted that rucaparib has been made available as a first-line maintenance treatment for eligible patients with advanced high-grade-epithelial ovarian, fallopian tube or primary peritoneal cancer, without a BRCA mutation and regardless of being HRD positive or negative, which accounts for 75% of ovarian NPM-GLB-RUC-178-(19-02-2025) cancer cases, 5” said Victoria Clare, CEO of Ovacome.
“Following chemotherapy, those who are living with ovarian cancer need treatment options, and this decision is very positive news for eligible patients, giving them and the clinicians treating them another important treatment option.”
The reimbursement of rucaparib follows approval from the Medicines and Healthcare products Regulatory Agency (MHRA) in January 2024, and is based on results of the international, randomised, double-blind, phase III ATHENA (GOG 3020/ENGOT-ov45) (NCT03522246) trial.
The ATHENA-MONO arm of the trial evaluated rucaparib monotherapy as a maintenance treatment for 538 patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.
In the ATHENA-MONO arm of the trial, rucaparib significantly improved investigator-assessed progression-free survival (PFS) compared with placebo in women6.
The safety profile observed in the ATHENA-MONO trial was consistent with both the current U.S. and European licenses for rucaparib.
Source: pharma&
References:
1 National Institute for Health and Care Excellence. Final Draft Guidance, Rucaparib for maintenance
treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy. Available at https://www.nice.org.uk/guidance/gid-ta10999/documents/674 Accessed February 2025.
2 Cancer Research UK. Ovarian cancer statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-
type/ovarian-cancer. Accessed February 2025.
3 Ovarian Cancer Action. Ovarian cancer diagnosis. Available at: https://ovarian.org.uk/ovarian-cancer/ovarian-cancer-diagnosis. Accessed February 2025.
4 Global Cancer Observatory. Ovary. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/25-ovary-fact-sheet.pdf. Accessed
February 2025.
5 Miller R. et al. Ovarian Cancer Therapy: Homologous Recombination Deficiency as a Predictive Biomarker of Response to PARP Inhibitors. OncoTargets & Therapy. 2022 Oct 4;15: 1105-1117.
6 Monk BJ et al. A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45). J Clin Oncol. 2022 Dec 1;40(34):3952-3964.
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