Puma Biotechnology Announces Results of CHMP Reexamination of MAA for Neratinib for Extended Adjuvant Treatment of HER2-Posit...
June 26 2018 - 8:51AM
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 positive trend vote
recommending the approval of the Marketing Authorisation
Application (MAA) for neratinib for the extended adjuvant treatment
of early stage HER2-positive hormone receptor positive breast
cancer. Today’s decision follows a reexamination of the negative
opinion announced by the CHMP at its formal meeting with the
Company to discuss the MAA on February 23, 2018. The CHMP
communicated its intention to hold a final vote at its next
meeting.
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,
including statements regarding the CHMP opinion, the basis for its
opinion regarding the Company’s MAA, and steps Puma may take in the
future to gain marketing approval in Europe. All statements other
than historical facts are forward-looking statements and are based
on our current expectations, forecasts and assumptions.
Forward-looking statements involve risks and uncertainties that
could cause our actual results to differ materially from the
anticipated results and expectations expressed in these
forward-looking statements. These risk and uncertainties are
identified in our Annual Report on Form 10-K for the year ended
December 31, 2017, our Quarterly Report on Form 10-Q for the
quarter ended March 31, 2018 and any subsequent documents we file
with the SEC. Readers are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
hereof. We assume no obligation to update these forward-looking
statements except as required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20180626005940/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorRusso
PartnersDavid Schull or Amiad Finkelthal, +1 212 845
4200david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.com
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