LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) has been advised that its
licensing partner CANbridge Pharmaceutical Inc received confirmation
that China’s National Medical Products Administration (NMPA) has
accepted its New Drug Application (NDA) for NERLYNX® (neratinib) for
the extended adjuvant treatment of adult patients with early stage
HER2-positive breast cancer, following adjuvant trastuzumab
based-therapy. NERLYNX was approved in the United States for the
same indication in July 2017 and in the European Union for the extended
adjuvant treatment of hormone receptor-positive HER2-positive early
stage breast cancer in September 2018.
James Xue, PhD, Founder, Chairman and CEO of CANbridge Pharmaceutical
Inc, said, “The fact that CANbridge has so rapidly advanced CAN030
(neratinib), our first Western-approved target therapy, along the
regulatory pathway in China demonstrates our capacity to new bring
medical breakthroughs to China swiftly, where they can potentially
address the unmet needs of millions. HER2-positive breast cancer is on
the rise in China, particularly in younger women, and the patient
outcomes, with limited current treatment options relative to Western
countries, are not as good. We are committed to bringing this important
new treatment to these patients, as well as to exploring its potential
application in other HER2-positive cancers, such as gastric.”
“We are very pleased with the progress that CANbridge has made in the
regulatory process for NERLYNX in greater China. This is a testament to
their dedication to helping breast cancer patients in China and we are
very pleased to see this dedication to the patients, which helps Puma to
recognize its goal of making NERLYNX available to patients worldwide,”
said Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology. “We look forward to CANbridge’s continued progress in
this regulatory process for NERLYNX.”
About HER2-Positive Breast Cancer
Approximately 20 to 25 percent 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.
About CANbridge Pharmaceutical
CANbridge Pharmaceutical Inc is a clinical-stage bio-pharmaceutical
company accelerating development and commercialization of specialty
healthcare products for serious and critical medical conditions in China
and North Asia (Korea and Taiwan). The company develops partnerships
with Western bio-pharmaceutical companies with clinical-stage
pharmaceutical, medical device or diagnostic products that are either
unavailable in China/North Asia, or address medical needs that are
underserved in the region. It also licenses, or obtains exclusive rights
to commercialize, drug and device products that are approved in their
home markets for commercialization in China and North Asia. CANbridge
has exclusive rights to develop and commercialize Puma Biotechnology’s
NERLYNX® (neratinib) in China, Taiwan, Hong Kong and Macao
(collectively, greater China).
CANbridge is privately-held and headquartered in Beijing, China. Further
information may be found at www.canbridgepharma.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. Puma in-licenses the global development and
commercialization rights to three drug candidates — PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral 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. NERLYNX was granted marketing
authorization by the European Commission for the extended adjuvant
treatment of hormone receptor-positive HER2-positive early stage breast
cancer in September 2018. NERLYNX is a registered trademark of Puma
Biotechnology, Inc.
Further information about Puma Biotechnology may be found at
www.pumabiotechnology.com
.
Important Safety Information Regarding NERLYNX
®
(neratinib)
U.S. Indication
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated
for the extended adjuvant treatment of adult patients with HER2
overexpressed/amplified breast cancer, to follow adjuvant
trastuzumab-based therapy.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
• Diarrhea: Aggressively manage diarrhea occurring despite
recommended prophylaxis with additional antidiarrheals, fluids, and
electrolytes as clinically indicated. Withhold NERLYNX in patients
experiencing severe and/or persistent diarrhea. Permanently discontinue
NERLYNX in patients experiencing Grade 4 diarrhea or Grade≥ 2 diarrhea
that occurs after maximal dose reduction.
• Hepatotoxicity: Monitor liver function tests monthly for the
first 3 months of treatment, then every 3 months while on treatment and
as clinically indicated. Withhold NERLYNX in patients experiencing Grade
3 liver abnormalities and permanently discontinue NERLYNX inpatients
experiencing Grade 4 liver abnormalities.
• Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise
patients of potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common adverse reactions (≥ 5%) were
diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis,
decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail
disorder, dry skin, abdominal distention, epistaxis, weight decreased
and urinary tract infection.
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology,
Inc. at 1-844-NERLYNX (1-844-637-5969) and
www.NERLYNX.com
or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
.
DRUG INTERACTIONS:
-
Gastric acid reducing agents: Avoid concomitant use with proton pump
inhibitors (PPI) and H2-receptor antagonists. Separate NERLYNX by 3
hours after antacid dosing.
-
Strong or moderate CYP3A4 inhibitors: Avoid concomitant use.
-
Strong or moderate CYP3A4 inducers: Avoid concomitant use.
-
P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of
narrow therapeutic agents that are P-gp substrates when used
concomitantly with NERLYNX.
USE IN SPECIFIC POPULATIONS:
•Lactation: Advise women not to breastfeed.
Please see
Full
Prescribing Information
for additional safety information.
To help ensure patients have access to NERLYNX, Puma has implemented the
Puma Patient Lynx support program to assist patients and health care
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 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.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Important EU NERLYNX
®
(neratinib)
Safety Information
All suspected adverse reactions should be reported in accordance with
the national reporting system.
The adverse reactions described in this section were identified in the
randomized Phase 3 clinical trial (n=2840). The most common adverse
reactions of any grade were diarrhoea (93.6%), nausea (42.5%), fatigue
(27.3%), vomiting (26.8%), abdominal pain (22.7%), rash (15.4%),
decreased appetite (13.7%), abdominal pain upper (13.2%), stomatitis
(11.2%), and muscle spasms (10.0%).
The most common Grade 3-4 adverse reactions were diarrhoea (Grade 3,
36.9% and Grade 4, 0.2%) and vomiting (Grade 3, 3.4% and Grade 4, 0.1%).
Adverse reactions reported as serious included diarrhoea (1.9%),
vomiting (1.3%), dehydration (1.1%), nausea (0.5%), alanine
aminotransferase increased (0.4%), aspartate aminotransferase increased
(0.4%), abdominal pain (0.3%), fatigue (0.3%) and decreased appetite
(0.2%).
For full European prescribing information, please refer to the
NERLYNX (neratinib) Summary of Product Characteristics on the European
Medicines Agency website (
http://www.ema.europa.eu/ema/
).
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding potential indications for NERLYNX and the worldwide
expansion of NERLYNX. All forward-looking statements involve risks and
uncertainties that could cause Puma’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 risk factors
disclosed in the periodic and current reports filed by Puma with the
Securities and Exchange Commission from time to time, including Puma’s
Annual Report on Form 10-K for the year ended December 31, 2017. Readers
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. Puma assumes no
obligation to update these forward-looking statements, except as
required by law.
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