Phase III ExteNET Trial in Early Stage HER2-Positive Breast Cancer
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
announced the release of two abstracts on its drug neratinib that will
be presented at the European Society for Medical Oncology (ESMO) 2017
Congress, which will be held September 8 – 12 in Madrid, Spain.
Abstracts are available to the public online on the ESMO website: www.esmo.org.
Abstract #1490: Neratinib after trastuzumab-based adjuvant
therapy in early stage HER2-positive breast cancer: 5-year
analysis of the Phase III ExteNET trial.
The abstract will be
presented as a proffered paper oral session on Friday, September 8.
Abstract #177P: Effects of neratinib on health-related quality
of life in early stage HER2-positive breast cancer.
The
abstract will be displayed as a poster on Monday, September 11.
The ExteNET trial is a double-blind, placebo-controlled, Phase III trial
of neratinib versus placebo after adjuvant treatment with trastuzumab
(Herceptin) in women with early stage HER2-positive breast cancer.
U.S. Approval of Neratinib (NERLYNX™)
Neratinib was approved by the U.S. Food and Drug Administration in July
2017 for the extended adjuvant treatment of adult patients with early
stage HER2-overexpressed/amplified breast cancer, following adjuvant
trastuzumab-based therapy, and is marketed in the United States as
NERLYNX™ (neratinib) tablets.
About HER2-Positive Breast Cancer
Approximately 20% to 25% of breast cancer tumors over-express the HER2
protein. HER2-positive breast cancer is often more aggressive than other
types of breast cancer, increasing the risk of disease progression and
death. Although research has shown that trastuzumab can reduce the risk
of early stage HER2-positive breast cancer returning after surgery, up
to 25% of patients treated with trastuzumab experience recurrence.
Indication
NERLYNX™ is a tyrosine kinase inhibitor indicated for the extended
adjuvant treatment of adult patients with early stage
HER2-overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.
To help ensure patients have access to NERLYNX, Puma has implemented
the Puma Patient Lynx support program to assist patients and healthcare
providers with reimbursement support and referrals to resources that can
help with financial assistance. More information on the Puma
Patient Lynx program can be found at
www.NERLYNX.com
or 1-855-816-5421.
The full prescribing information for NERLYNX is available at
www.NERLYNX.com
.
The recommended dose of NERLYNX is 240 mg (six 40 mg tablets) given
orally once daily with food, continuously for one year. Antidiarrheal
prophylaxis should be initiated with the first dose of NERLYNX and
continued during the first 2 months (56 days) of treatment and as needed
thereafter.
Important Safety Information
There are possible side effects of NERLYNX. Patients must contact their
doctor right away if they experience any of these symptoms. NERLYNX
treatment may be stopped or the dose may be lowered if the patient
experiences any of these side effects.
Diarrhea
Diarrhea is a common side effect of NERLYNX. The diarrhea
may be severe, and you may get dehydrated. Your healthcare provider
should prescribe the medicine loperamide for you during your first 2
cycles (56 days) of NERLYNX and then as needed. To help prevent or
reduce diarrhea:
-
You should start taking loperamide with your first dose of NERLYNX.
-
Keep taking loperamide during the first 2 cycles (56 days) of NERLYNX
treatment and then as needed. Your healthcare provider will tell you
exactly how much and how often to take loperamide.
-
While taking loperamide, you and your healthcare provider should try
to keep the number of bowel movements that you have at 1 or 2 bowel
movements each day.
-
Tell your healthcare provider if you have more than 2 bowel movements
in 1 day, or if you have diarrhea that does not go away.
Contact your healthcare provider right away if you have severe
diarrhea or if you have diarrhea along with weakness, dizziness or fever.
Liver Problems
Changes in liver function tests are common with NERLYNX. The patient’s
doctor will do tests before starting treatment, monthly during the first
3 months, and then every 3 months as needed during treatment with
NERLYNX. NERLYNX treatment may be stopped or the dose may be lowered if
your liver tests show severe problems. Symptoms of liver problems may
include tiredness, nausea, vomiting, pain in the right upper stomach
area (abdomen), fever, rash, itching or yellowing of your skin or whites
of your eyes.
Pregnancy
Patients should tell their doctor if they are planning to become
pregnant, are pregnant, plan to breastfeed, or are breastfeeding.
NERLYNX can harm your unborn baby. Birth control should be used while a
patient is receiving NERLYNX and for at least 1 month after the last
dose. If patients are exposed to NERLYNX during pregnancy, they must
contact their healthcare provider right away.
Common side effects in patients treated with NERLYNX
In clinical studies, the most common side effects seen in patients
taking NERLYNX were diarrhea, nausea, abdominal pain, fatigue, vomiting,
rash, stomatitis (dry or inflamed mouth, or mouth sores), decreased
appetite, muscle spasms, dyspepsia, changes in liver blood test results,
nail problems, dry skin, abdominal distention, weight loss and urinary
tract infection.
Patients should tell their doctor right away if they are experiencing
any side effects. Report side effects to the FDA at 1-800-FDA-1088 or
http://www.FDA.gov/medwatch
.
Patients and caregivers may also report side effects to Puma
Biotechnology at 1-844-NERLYNX (1-844-637-5969).
Please see Full Prescribing Information, available at
www.NERLYNX.com
.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the development and commercialization of innovative products to enhance
cancer care. The Company in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib
(oral)), PB272 (neratinib (intravenous)) and PB357. NERLYNX™ (neratinib)
is approved for commercial use by prescription in the United States as
extended adjuvant therapy for early stage HER2-positive breast cancer
following adjuvant trastuzumab-based therapy and is marketed as NERLYNX.
Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks
signal transduction through the epidermal growth factor receptors, HER1,
HER2 and HER4. Currently, the Company is primarily focused on the
commercialization of NERLYNX and the continued development of its other
advanced drug candidates directed at the treatment of HER2-positive
breast cancer. The Company believes that NERLYNX has clinical
application in the potential treatment of several other cancers that
over-express or have a mutation in HER2.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding the benefits of NERLYNX™ and neratinib, the
Company’s clinical trials and the announcement of data relative to those
trials. All forward-looking statements included in this press release
involve risks and uncertainties that could cause the Company’s actual
results to differ materially from the anticipated results and
expectations expressed in these forward-looking statements. These
statements are based on current expectations, forecasts and assumptions,
and actual outcomes and results could differ materially from these
statements due to a number of factors, which include, but are not
limited to, the fact that the Company has only recently commenced
commercialization and shipment of its only FDA approved product; the
Company’s dependence upon the commercial success of NERLYNX (neratinib);
the Company’s history of operating losses and its expectation that it
will continue to incur losses for the foreseeable future; risks and
uncertainties related to the Company’s ability to achieve or sustain
profitability; the Company’s ability to predict its future prospects and
forecast its financial performance and growth; failure to obtain
sufficient capital to fund the Company’s operations; the effectiveness
of sales and marketing efforts; the Company’s ability to obtain FDA
approval or other regulatory approvals in the United States or elsewhere
for other indications for neratinib or other product candidates; the
challenges associated with conducting and enrolling clinical trials; the
risk that the results of clinical trials may not support the Company’s
drug candidate claims; even if approved, the risk that physicians and
patients may not accept or use the Company’s products; the Company’s
reliance on third parties to conduct its clinical trials and to
formulate and manufacture its drug candidates; risks pertaining to
securities class action, derivative and defamation lawsuits; the
Company’s dependence on licensed intellectual property; and the other
risk factors disclosed in the periodic and current reports filed by the
Company with the Securities and Exchange Commission from time to time,
including the Company’s Quarterly Report on Form 10-Q for the quarter
ended June 30, 2017. Readers are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date
hereof. The Company assumes no obligation to update these
forward-looking statements, except as required by law.
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