Clovis Oncology Announces Availability of and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Switzerland

Clovis Oncology Announces Availability of and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Switzerland




Clovis Oncology Announces Availability of and Reimbursement for Rubraca® (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Switzerland

  • Rubraca (rucaparib) offers a new maintenance treatment option for eligible women with relapsed, platinum-sensitive ovarian cancer, who harbor either a BRCA1/2 mutation or are BRCA wild-type
  • Rubraca provided statistically significant improvement in progression-free survival (PFS) versus placebo in all ovarian cancer patients studied1
  • Some patients with residual disease at ARIEL3 study entry who were treated with Rubraca showed further reduction in tumor burden, including complete responses1
  • Most common Grade ≥3 adverse reaction was anemia; the only serious adverse reaction occurring in >2 percent of patients was anemia2
  • Rubraca is commercially available in Germany, United Kingdom, Italy, Spain, France, Netherlands, United States of America and now in Switzerland

BOULDER, Colo.–(BUSINESS WIRE)–Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that Rubraca (rucaparib) is now available and reimbursed in Switzerland. 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

“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: MedInfo.CH@clovisoncology.com. Toll-free phone line: +41 (0)800677526. Date of revision: November 2020.

About Clovis Oncology

Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis Oncology targets development programs at specific subsets of cancer populations, and simultaneously develops, with partners, for those indications that require them, diagnostic tools intended to direct a compound in development to the population that is most likely to benefit from its use. Clovis Oncology is headquartered in Boulder, Colorado, with additional office locations in the U.S. and Europe.

To the extent that statements contained in this press release are not descriptions of historical facts regarding Clovis Oncology, they are forward-looking statements reflecting the current beliefs and expectations of management. Examples of forward-looking statements contained in this press release include, among others, statements regarding our plans to launch Rubraca in additional European countries, including availability of Rubraca in Switzerland, and to make Rubraca available to additional eligible patients. Such forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from that expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the market potential of Rubraca, including the performance of our sales and marketing efforts and the success of competing drugs and therapeutic approaches, the performance of our third-party manufacturers and our distribution network, our clinical development programs for our drug candidates and those of our partners, and actions by the FDA, the EMA or other regulatory authorities regarding data required to support drug applications and whether to accept or approve drug applications that may be filed, as well as their decisions regarding drug labeling, reimbursement and pricing. Clovis Oncology does not undertake to update or revise any forward-looking statements. A further description of risks and uncertainties can be found in Clovis Oncology’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its reports on Form 10-Q and Form 8-K.

References

  1. Coleman RL, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2017;390:1949–61.
  2. Summary of Product Characteristics Rubraca 200, 250, 300 mg film-coated tablets. Available at: https://www.ema.europa.eu/en/documents/product-information/rubraca-epar-product-information_en.pdf (accessed December 2019) and www.swissmedicinfo.ch (accessed July 2021)
  3. Swiss Cancer League, Cancer in Switzerland: important figures. Available at https://www.krebsliga.ch/fileadmin/downloads/sheets/zahlen-krebs-in-der-schweiz.pdf; Accessed July 2021
  4. Cancer prevalence in Switzerland by cancer type and gender 2015. Available at : https://de.statista.com/statistik/daten/studie/461216/umfrage/krebspraevalenz-in-der-schweiz-nach-krebsart-und-geschlecht/. Accessed July 2021
  5. Hanley G, et al. A population-based analysis of germline BRCA1 and BRCA2 testing among ovarian cancer patients in an era of histotype-specific approaches to ovarian cancer prevention. BMC Cancer 18, 254 (2018)
  6. Huang, Yong-Wen. Association of BRCA1/2 mutations with ovarian cancer prognosis: An updated meta-analysis. Medicine vol. 97,2 (2018)
  7. New cases and deaths by cancer location, 2013-2017 https://www.bfs.admin.ch/bfs/de/home/statistiken/gesundheit/gesundheitszustand/krankheiten/krebs/spezifische.assetdetail.14816151.html, accessed July 2021

i Federal public law institution, attached to the Federal Department of Home Affairs

Contacts

Clovis investor contacts:
Anna Sussman, +1 303.625.5022

asussman@clovisoncology.com
or

Breanna Burkart, +1 303.625.5023

bburkart@clovisoncology.com

Clovis media contacts:

Europe

Jake Davis, +44 (0) 203.946.3538

Jake.Davis@publicisresolute.com