LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee of the
European Medicines Agency (EMA), has issued its Day-180 List of
Outstanding Issues in the process of their ongoing regulatory review of
Puma’s Marketing Authorisation Application (MAA) for neratinib for the
extended adjuvant treatment of HER2-positive early stage breast cancer
in patients who have previously been treated with trastuzumab
(Herceptin®)-based adjuvant therapy.
The CHMP has requested additional data analyses related to the safety
and efficacy of neratinib and has instituted a clock stop in order to
allow Puma time to respond to this List of Outstanding Issues. The CHMP
has set a deadline of December 22, 2017 for Puma to respond to the list.
Puma expects the CHMP to issue an opinion regarding the MAA for
neratinib in the first quarter of 2018.
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. 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™. NERLYNX 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 development of the oral version of NERLYNX, and its most
advanced drug candidates are directed at the treatment of HER2-positive
breast cancer. The Company believes that NERLYNX has clinical
application in the treatment of several other cancers as well, including
non-small cell lung cancer and other tumor types 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 expected timing with respect to CHMP's
opinion regarding the MAA for neratinib. 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 currently has
no product revenue, 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
for 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 Annual Report on
Form 10-K for the year ended December 31, 2016. 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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