- Clovis seeks U.S. approval for rucaparib as
monotherapy treatment for patients with BRCA1/2-mutant recurrent,
metastatic castrate-resistant prostate cancer
- FDA submission based on data from TRITON
clinical program in advanced prostate cancer
- FDA has assigned PDUFA date of May 15,
2020
Clovis Oncology, Inc. (NASDAQ: CLVS) announced today that the
U.S. Food and Drug Administration (FDA) has accepted the company’s
supplemental New Drug Application (sNDA) for Rubraca® (rucaparib)
and granted priority review status to the application with a
Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis
submitted the sNDA submission for rucaparib as a monotherapy
treatment of adult patients with BRCA1/2-mutant recurrent,
metastatic castrate-resistant prostate cancer in November 2019.
“Recently presented data suggests that Rubraca may play a
meaningful role in the treatment of patients with BRCA1/2-mutant
recurrent, metastatic castrate-resistant prostate cancer, and this
filing represents an important milestone for Clovis as it brings us
one step closer to potentially making this valuable therapy
available,” said Patrick J. Mahaffy, President and CEO of Clovis
Oncology. “We are encouraged by the FDA’s decision to grant
priority review to the Rubraca application, which focuses on
eligible patients with advanced prostate cancer, for whom new
treatment options are very much needed.”
A priority review designation is granted to proposed medicines
that the FDA has determined have the potential, if approved, to
offer a significant improvement in the safety or effectiveness of
the treatment, prevention or diagnosis of a serious condition.
Priority designation shortens the review period from the standard
10 months to six months.
About Prostate Cancer
The American Cancer Society estimated that more than 175,000 men
in the United States would be diagnosed with prostate cancer in
2019, and the GLOBOCAN Cancer Fact Sheets estimated that
approximately 450,000 men in Europe were diagnosed with prostate
cancer in 2018. Castrate-resistant prostate cancer has a high
likelihood of developing metastases. Metastatic castrate-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. According to
the American Cancer Society, the five-year survival rate for mCRPC
is approximately 30 percent. Up to 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.
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.
Rubraca U.S. FDA Approved Indications
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 mutations (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, five 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 cytogenetic analysis. 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 Rubraca 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 or 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, 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.
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 review and
approval of the sNDA and submission, and availability of Rucaparib
to the patients with advanced prostate cancer. 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, the final approved
label for the prostate indication, and our assumptions and
expectations regarding the size of the patient population, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200115005158/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
or Christy Curran, 615.414.8668 clovismedia@sambrown.com
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Clovis Oncology (NASDAQ:CLVS)
Historical Stock Chart
From Sep 2023 to Sep 2024