Rubraca recommended as a treatment option
for BRCA-mutant mCRPC in the second line setting and as a
subsequent therapy; if the patient is not fit for chemotherapy,
rucaparib can be considered prior to taxane
Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that the
National Comprehensive Cancer Network® (NCCN) updated its Clinical
Practice Guidelines in Oncology for Prostate Cancer to include new
recommendations for Rubraca® (rucaparib) tablets.i In
addition to its ovarian cancer recommendations, Rubraca is now
recommended in the NCCN Guidelines® for the treatment of
BRCA-mutant patients with mCRPC under second-line treatment and
subsequent therapy as a Category 2A recommendation inclusive of the
following:
Rucaparib is a treatment option for patients with mCRPC and a
pathogenic BRCA1 or BRCA2 mutation (germline and/or somatic) who
have been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy. If the patient is not fit for
chemotherapy, rucaparib can be considered even if taxane-based
therapy has not been given.
“We are pleased that the NCCN has acknowledged the importance of
novel targeted therapies for the treatment of advanced prostate
cancer, and the need for new treatment options for patients with
BRCA mutations, including Rubraca, the first PARP inhibitor
approved for these patients,” said Patrick J. Mahaffy, President
and CEO of Clovis Oncology. “In particular, in the current COVID-19
environment, many patients would prefer to avoid chemotherapy,
which requires frequent clinical visits, in favor of an oral agent
that can be delivered directly to and taken at home.”
NCCN Guidelines are the recognized standard for clinical
direction and policy in cancer care and are the most thorough and
frequently updated clinical practice guidelines available in any
area of medicine.ii The NCCN prostate cancer panel’s decision to
include Rubraca as a Category 2A preferred option for the treatment
of patients with a BRCA mutation for second-line treatment and
subsequent therapy was based on the results of the Phase 2 TRITON2
study.
About Prostate Cancer
The American Cancer Society estimates that nearly 192,000 men in
the United States will be diagnosed with prostate cancer in
2020iii, and the GLOBOCAN Cancer Fact Sheets estimated that
approximately 450,000 men in Europe were diagnosed with prostate
cancer in 2018.iv Castration-resistant prostate cancer has a high
likelihood of developing metastases. Metastatic
castration-resistant prostate cancer, or mCRPC, is an incurable
disease, usually associated with poor prognosis. Approximately
43,000 men in the U.S. are expected to be diagnosed with mCRPC in
2020.v According to the American Cancer Society, the five-year
survival rate for mCRPC is approximately 30 percent.vi
Approximately 12 percent of patients with mCRPC harbor a
deleterious germline and/or somatic mutation in the genes BRCA1 and
BRCA2. These molecular markers may be used to select patients for
treatment with a PARP inhibitor.vii
Rubraca U.S. FDA Approved Indication
Rubraca is indicated for the treatment of adult patients with a
deleterious BRCA mutation (germline and/or somatic)-associated
metastatic castration-resistant prostate cancer (mCRPC) who have
been treated with androgen receptor-directed therapy and a
taxane-based chemotherapy.
This indication is approved under accelerated approval based on
objective response rate and duration of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials.
Select Important Safety Information
Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has
occurred in patients treated with Rubraca, and are potentially
fatal adverse reactions. In 1146 treated patients, MDS/AML occurred
in 20 patients (1.7%), including those in long term follow-up. Of
these, 8 occurred during treatment or during the 28 day safety
follow-up (0.7%). The duration of Rubraca treatment prior to the
diagnosis of MDS/AML ranged from 1 month to approximately 53
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. In
TRITON2, MDS/AML was not observed in patients with mCRPC (n=209)
regardless of homologous recombination deficiency (HRD)
mutation.
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 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 findings in genetic toxicity and animal reproduction
studies, advise male patients with female partners of reproductive
potential or who are pregnant to use effective methods of
contraception during treatment and for 3 months following last dose
of Rubraca. Advise male patients not to donate sperm during therapy
and for 3 months following the last dose of Rubraca.
Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were
fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT
elevation (33%), decreased appetite (28%), rash (27%), constipation
(27%), thrombocytopenia (25%), vomiting (22%), and diarrhea
(20%).
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.
Click here for full Prescribing Information for
Rubraca.
You may also report side effects to Clovis Oncology, Inc. at
1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US
toll-free).
About Accessing Rubraca
Rubraca is available in the United States through specialty
pharmacies and distributors. Clovis is committed to ensuring
Rubraca access for patients and offers eligible patients financial
and reimbursement support through Rubraca Connections. More
information about Rubraca Connections is available at
RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m.
and 8 p.m. Eastern Time, Monday through Friday.
About Rubraca (rucaparib)
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2
and PARP3 being developed in multiple tumor types, including
ovarian and metastatic castration-resistant prostate cancers, as
monotherapy, and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway.
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. Please visit www.clovisoncology.com for more
information.
This press release contains forward-looking statements (as
defined under the Private Securities Litigation Reform Act of 1995)
about the potential of Rubraca® (rucaparib) for the treatment of
adult patients with deleterious BRCA mutation (germline and/or
somatic)-associated metastatic castration-resistant prostate cancer
(mCRPC) who have been treated with androgen receptor-directed
therapy and a taxane-based chemotherapy, and reflects Clovis
Oncology’s current beliefs. As with any pharmaceutical product,
there are substantial risks and uncertainties in the process of
development and commercialization that could cause actual results
to differ materially from those expressed or implied by the
forward-looking statements. In particular, there are no guarantees
that future study results and patient experience will be consistent
with the study findings to date, that Rubraca will receive
regulatory approval for any future indications, or that it will
prove to be commercially successful. 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. All
forward-looking statements are based on information currently
available to the company, and Clovis Oncology does not undertake to
update or revise any forward-looking statements
i NCCN Clinical Practice Guidelines in Oncology (NCCN
Guidelines®) for Prostate Cancer V.2.2020. Accessed May 21, 2020.
ii NCCN website. About NCCN Guidelines.
https://www.nccn.org/professionals/default.aspx. Accessed May 27,
2020. iii American Cancer Society. Key Statistics for Prostate
Cancer.
https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
Accessed January 30, 2020. iv GLOBOCAN Cancer Fact Sheets: prostate
cancer. Prostate Cancer Estimated Incidence, Mortality and
Prevalence Worldwide in 2018.
https://gco.iarc.fr/today/data/factsheets/cancers/27-Prostate-fact-sheet.pdf.
Accessed February 4, 2020. v Cameron A. Wade and Natasha Kyprianou.
Profiling Prostate Cancer Therapeutic Resistance. International
Journal of Molecular Sciences. 2018, 19, 204.
https://www.mdpi.com/1422-0067/19/3/904/pdf. vi American Cancer
Society. Survival rates for prostate cancer.
https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed February 4, 2020. vii Abida W, Armenia J, Gopalan A, et
al. Prospective Genomic Profiling of Prostate Cancer Across Disease
States Reveals Germline and Somatic Alterations That May Affect
Clinical Decision Making. JCO Precis Oncol 2017: 1-16.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200528005462/en/
Clovis Investor Contacts: Anna Sussman, 303.625.5022
asussman@clovisoncology.com or Breanna Burkart, 303.625.5023
bburkart@clovisoncology.com
Clovis Media Contacts: U.S. Lisa Guiterman,
301.217.9353 clovismedia@sambrown.com
Europe Jake Davis, +44 (0) 20.3946.3538
Jake.Davis@publicisresolute.com
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Apr 2023 to Apr 2024