- European Commission (EC) marketing authorization is
anticipated Q1 2019
- Upon receipt of marketing authorization by the EC, Rubraca
will offer a new monotherapy option for the maintenance treatment
of adults with platinum-sensitive relapsed high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
response (complete or partial) to platinum-based
chemotherapy
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the
European Union’s (EU) European Medicines Agency (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion recommending an additional indication to include rucaparib
as monotherapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed high-grade epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in response
(complete or partial) to platinum-based chemotherapy. EC approval
is anticipated in the first quarter of 2019.
Once approved, Rubraca’s indication will expand beyond its
initial Marketing Authorization in Europe granted in May 2018 for
adult patients with platinum-sensitive, relapsed or progressive,
BRCA mutated (germline and/or somatic), high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer, who have
been treated with two or more prior lines of platinum-based
chemotherapy, and who are unable to tolerate further platinum-based
chemotherapy.
The CHMP’s positive opinion for this additional indication was
based on data from the phase 3 ARIEL3 clinical trial, which found
that rucaparib significantly improved progression-free survival in
all ovarian cancer patient populations studied.i
“The CHMP recommendation represents an important step forward
for women with recurrent ovarian cancer, for whom additional
treatment options are needed. The ARIEL3 trial demonstrated
rucaparib to be effective across all patient types, regardless of
their BRCA mutation status, and is the only PARP-inhibitor trial in
which independent radiological review reported a median
progression-free survival of more than one year across the entire
population studied,” said Professor Jonathan Ledermann, MD,
Professor of Medical Oncology, UCL Cancer Institute and UCL
Hospitals, London, global Principal Investigator for non-US sites
in the ARIEL3 study. “The meaningful efficacy data and tolerable
safety profile offers women diagnosed with relapsed ovarian cancer
a new therapy option.”
Ovarian cancer is the sixth deadliest cancer amongst women in
Europe, where more than 65,000 women are diagnosed annually.ii
Ovarian cancer is challenging to treat, and most women will relapse
after surgery and chemotherapy. The 80 to 85 percent of women
diagnosed in the later stages of the disease (III and IV) have
particularly poor outcomes.iii
“We are pleased that the CHMP recognizes the clinical relevance
of rucaparib in the maintenance treatment setting for European
women with relapsed platinum-sensitive ovarian cancer,” said
Patrick J. Mahaffy, President and CEO of Clovis Oncology. “This
brings us a step closer to delivering on our commitment to ensure
that women who may benefit from treatment with rucaparib have the
opportunity to do so. We seek to make ovarian cancer an actively
managed disease, rather than one that is treated and then wait for
recurrence. Rucaparib’s clinical benefit in the maintenance
treatment setting is supported by the pivotal ARIEL3 study, which
showed that Rubraca provided benefit in all ovarian cancer patient
populations studied.”
About the ARIEL3 Pivotal Study
ARIEL3 is a double-blind, placebo-controlled trial of rucaparib
that enrolled 564 women with platinum-sensitive, high-grade
ovarian, fallopian tube, or primary peritoneal cancer. The primary
efficacy analysis evaluated three prospectively defined molecular
sub-groups in a step-down manner: 1) BRCA mutant (BRCAmut+); 2) HRD
positive (HRD+) inclusive of BRCA mutant; and finally, 3) the
intent-to-treat population, or all patients treated in ARIEL3. The
study achieved its primary endpoint of improved PFS by investigator
review in each of three populations.
About Rubraca® (rucaparib)
Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and
PARP3 being developed in multiple tumor types, including ovarian,
metastatic castration-resistant prostate, and bladder cancers, as
monotherapy, and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway.
In October 2018, Rubraca was granted Breakthrough Therapy
Designation by the FDA as monotherapy treatment of adult patients
with BRCA1/2-mutated mCRPC who have received at least one prior
androgen receptor (AR)-directed therapy and taxane-based
chemotherapy.
Clovis holds worldwide rights for Rubraca. Rubraca is an
unlicensed medical product outside of the U.S. and Europe.
Rucaparib EU Authorized Use
Rucaparib is indicated for adult patients with platinum
sensitive, relapsed or progressive, BRCA mutated (germline and/or
somatic), high-grade epithelial ovarian, fallopian tube, or primary
peritoneal cancer, who have been treated with two or more prior
lines of platinum-based chemotherapy, and who are unable to
tolerate further platinum-based chemotherapy.
Click here to access the current Summary of Product
Characteristics. Healthcare professionals should report any
suspected adverse reactions via their national reporting
systems.
Rucaparib U.S. FDA Approved Indications and Important Safety
Information
Rubraca is indicated as monotherapy for the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy.
Rubraca is indicated as monotherapy for the treatment of adult
patients with deleterious BRCA mutation (germline and/or somatic)
associated epithelial ovarian, fallopian tube, or primary
peritoneal cancer who have been treated with two or more
chemotherapies and selected for therapy based on an FDA-approved
companion diagnostic for Rubraca.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML)
occur uncommonly in patients treated with Rubraca and are
potentially fatal adverse reactions. In approximately 1100 treated
patients, MDS/AML occurred in 12 patients (1.1%), including those
in long term follow-up. Of these, 5 occurred during treatment or
during the 28-day safety follow-up (0.5%). The duration of Rubraca
treatment prior to the diagnosis of MDS/AML ranged from 1 month to
approximately 28 months. The cases were typical of secondary
MDS/cancer therapy-related AML; in all cases, patients had received
previous platinum-containing regimens and/or other DNA damaging
agents.
Do not start Rubraca until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤ Grade
1).
Monitor complete blood counts for cytopenia at baseline and
monthly thereafter for clinically significant changes during
treatment. For prolonged hematological toxicities (> 4 weeks),
interrupt Rubraca or reduce dose (see Dosage and Administration
(2.2) in full Prescribing Information) and monitor blood counts
weekly until recovery. If the levels have not recovered to Grade 1
or less after 4 weeks or if MDS/AML is suspected, refer the patient
to a hematologist for further investigations, including bone marrow
analysis and blood sample for cytogenetics. If MDS/AML is
confirmed, discontinue Rubraca.
Based on its mechanism of action and findings from animal
studies, Rubraca can cause fetal harm when administered to a
pregnant woman. Apprise pregnant women of the potential risk to a
fetus. Advise females of reproductive potential to use effective
contraception during treatment and for 6 months following the last
dose of Rubraca.
Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1-4) were
nausea (76%), fatigue/asthenia (73%), abdominal pain/distention
(46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation
(38%), constipation (37%), vomiting (37%), diarrhea (32%),
thrombocytopenia (29%), nasopharyngitis/upper respiratory tract
infection (29%), stomatitis (28%), decreased appetite (23%), and
neutropenia (20%).
Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade
1-4) were increase in creatinine (98%), decrease in hemoglobin
(88%), increase in cholesterol (84%), increase in alanine
aminotransferase (ALT) (73%), increase in aspartate
aminotransferase (AST) (61%), decrease in platelets (44%), decrease
in leukocytes (44%), decrease in neutrophils (38%), increase in
alkaline phosphatase (37%), and decrease in lymphocytes (29%).
Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%;
Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting
(46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased
appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea
(21%), and thrombocytopenia (21%).
Most common laboratory abnormalities in Study 10 and ARIEL2 (≥
35%; Grade 1-4) were increase in creatinine (92%), increase in
alanine aminotransferase (ALT) (74%), increase in aspartate
aminotransferase (AST) (73%), decrease in hemoglobin (67%),
decrease in lymphocytes (45%), increase in cholesterol (40%),
decrease in platelets (39%), and decrease in absolute neutrophil
count (35%).
Co-administration of rucaparib can increase the systemic
exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may
increase the risk of toxicities of these drugs. Adjust dosage of
CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically
indicated. If co-administration with warfarin (a CYP2C9 substrate)
cannot be avoided, consider increasing frequency of international
normalized ratio (INR) monitoring.
Because of the potential for serious adverse reactions in
breast-fed children from Rubraca, advise lactating women not to
breastfeed during treatment with Rubraca and for 2 weeks after the
last dose.
You may report side effects to the FDA at 1-800-FDA-1088 or
www.fda.gov/MedWatch. You may also report side effects to Clovis
Oncology, Inc. at 1-844-258-7662.
Click here for full Prescribing Information and additional
Important Safety Information.
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,
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, and has additional
offices in San Francisco and Oakland, California and Cambridge, UK.
Please visit clovisoncology.com for more information.
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 expectation of timing for European
Commission approval of rucaparib for the maintenance treatment
indication. 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 actions by the FDA, the EMA or other regulatory authorities
regarding whether to approve drug applications that may be filed,
as well as their decisions that may affect drug labeling, pricing
and reimbursement, and other matters that could affect the
availability or commercial potential of our drug candidates or
companion diagnostics. 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.
i 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;390:1949-1961.ii World Health Organization.
Globocan 2012: estimated cancer incidence, mortality and prevalence
worldwide in 2012. Accessed 23 February 2018.iii American Cancer
Society. Survival rates for ovarian cancer, by stage.
https://www.cancer.org/cancer/ovarian-cancer/detection-diagnosis-staging/survival-rates.html
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version on businesswire.com: https://www.businesswire.com/news/home/20181213005680/en/
Clovis Investor Contacts:Anna Sussman,
303.625.5022asussman@clovisoncology.comorBreanna Burkart,
303.625.5023bburkart@clovisoncology.comorClovis Media
Contacts:U.S.Lisa Guiterman,
301.217.9353clovismedia@sambrown.comorChristy Curran,
615.414.8668clovismedia@sambrown.comorEUAnn Hughes, +44 (0)
7956 700 790Ann.Hughes@publicisresolute.com
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