LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has adopted a negative opinion, recommending the refusal of the
Marketing Authorisation Application (MAA) for neratinib for the extended
adjuvant treatment of early stage HER2-positive breast cancer. On
January 23, 2018, Puma announced that the CHMP had communicated a
negative trend vote after meeting with the Company to discuss the MAA
and that a negative trend vote meant it was unlikely that CHMP would
provide a positive opinion related to the Company’s MAA at the formal
CHMP meeting. The CHMP has noted that Puma may request a re-examination
of the opinion and that a letter of intent to seek re-examination should
be submitted within 15 days of acknowledgement of receipt of the final
opinion package. Puma plans to submit this request in accordance with
this timeline.
CHMP’s vote was based on the results from both the Phase III ExteNET
trial in extended adjuvant early stage HER2-positive breast cancer and
the Phase II CONTROL trial in extended adjuvant early stage
HER2-positive breast cancer.
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.
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, 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 is a registered trademark of Puma
Biotechnology, Inc.
IMPORTANT SAFETY INFORMATION
NERLYNX
®
(neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a 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.
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 in
patients 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.
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.
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.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the
timing and substance of CHMP’s decision regarding the Company’s MAA upon
re-examination of its negative opinion, and steps to be taken to gain
marketing approval in Europe. All forward-looking statements 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 September 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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