On August 24, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that Rubraca (rucaparib) is now available and reimbursed in Switzerland (Press release, Clovis Oncology, AUG 24, 2021, View Source [SID1234586850]). The Swiss authority responsible for the authorization and supervision of therapeutic products (Swissmedic)i gave a positive recommendation for Rubraca as maintenance treatment for recurrent platinum sensitive ovarian cancer.2 Rubraca is indicated for eligible patients regardless of BRCA status, which means it can be prescribed for women who harbor a BRCA mutation or who are BRCA wild-type.2
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"PARP inhibition is the major improvement of the last years in the treatment of ovarian cancer," said Prof. Dr. med. Viola Heinzelmann-Schwarz, Head of the Department of Gynaecology and Gynaecological Oncology at the University Hospital Basel.
Approximately 600 women are diagnosed with ovarian cancer in Switzerland every year, which equates to 1 to 2 new diagnoses every day.3 It is the third most frequent gynecological cancer in Switzerland.4 In addition, up to approximately 25 percent of patients harbor a germline BRCA1/2 mutation correlating to responsiveness to therapy, while the majority of women who are diagnosed are BRCA wild-type will have a worse prognosis and limited therapeutic options.5,6 Despite advancements in treatment and care, on average 500 women in Switzerland still die each year.7
The Swissmedic authorization is based on data from the pivotal phase 3 ARIEL3 clinical trial, which found that Rubraca significantly improved PFS in all ovarian cancer patient populations studied.1 ARIEL3 successfully achieved its primary endpoint of extending investigator-assessed PFS versus placebo in all patients treated (intention-to-treat, or ITT), population, regardless of BRCA status (median 10.8 months vs 5.4 months).1,2 In addition, it successfully achieved the key secondary endpoint of extending PFS by independent radiological review versus placebo in all patients treated (ITT), regardless of BRCA status (median 13.7 months vs 5.4 months).2 The overall safety profile of Rubraca is based on data from 937 patients with ovarian cancer treated with Rubraca monotherapy in clinical trials.2
"We are pleased to make Rubraca available in Switzerland and offer a new maintenance treatment option for eligible women with relapsed ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "There has been a significant need for additional treatment options for women with relapsed ovarian cancer, and we are proud that women who may benefit will have access to rucaparib. We remain committed to making rucaparib available to eligible patients in the US and Europe."
About Rubraca (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 that is being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancer (mCRPC), as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.
Click here and search for Rubraca to access the Swiss PI.
Healthcare professionals should report any suspected adverse reactions via their national reporting systems. Click here to access the Swiss national reporting system.
Rubraca (Rucaparib) 200mg, 250mg and 300mg film-coated tablets:
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected new or serious adverse reactions. Active substance: rucaparib. Composition: film-coated tablet containing 200 mg, 250 mg or 300 mg rucaparib as rucaparib camsylate. Excipients: Tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b), brilliant blue FCF aluminium lake (E133), indigo carmine aluminium lake (E132). Indications/Uses: Rubraca is indicated for the maintenance therapy of adult patients with advanced, platinum-sensitive, relapsed, high-grade serous ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial remission following a platinum-based chemotherapy. Contraindications: hypersensitivity to the active substance or any of the excipients listed under Composition. Breastfeed during treatment with Rubraca and for 2 weeks following the last dose. Undesirable effects: Very common: anaemia, thrombocytopenia, neutropenia, decreased appetite, blood creatinine increased, dysgeusia, dizziness, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, alanine aminotransferase increased, aspartate aminotransferase increased, photosensitivity reaction, fatigue, pyrexia. Common: myelodysplastic syndrome / acute myeloid leukaemia, leukopenia, lymphopenia, febrile neutropenia, dehydration, hypercholesterolaemia, dyspnoea, transaminases increased, rash maculo-papular, palmar-plantar erythrodysaesthesia syndrome, erythema. Prescription status: prescription. Other information: see product information. Marketing authorisation holder: Clovis Oncology Switzerland GmbH, Seefeldstrasse 69, 8008 Zurich. Medical information: Email: [email protected]. Toll-free phone line: +41 (0)800677526. Date of revision: November 2020.