- 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
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
- 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.
- 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)
- 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
- 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
- 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)
- Huang, Yong-Wen. Association of BRCA1/2 mutations with ovarian
cancer prognosis: An updated meta-analysis. Medicine vol. 97,2
(2018)
- 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
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210823005497/en/
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
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