Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced that the U.S. Food and Drug Administration (FDA)
approved a supplemental New Drug Application (sNDA) for neratinib
in combination with capecitabine for the treatment of adult
patients with advanced or metastatic HER2-positive breast cancer
who have received two or more prior anti-HER2-based regimens in the
metastatic setting. The sNDA approval was based on results of the
Phase III NALA trial, a randomized controlled trial of neratinib
plus capecitabine in patients with HER2-positive metastatic breast
cancer who have received two or more prior anti-HER2-based
regimens.
“Although there have been many new treatment options for
patients with HER2-positive breast cancer, patients still need
additional treatment options once they progress,” said Alan H.
Auerbach, Chief Executive Officer and President of Puma. “Based on
the results of our NALA data, we believe NERLYNX® could be a
promising therapeutic opportunity for these patients.”
Adam M. Brufsky, MD, Ph.D., of Magee-Womens Hospital and the
Hillman Cancer Center at the University of Pittsburgh Medical
Center, added, “Together with the NALA investigators around the
world, I am pleased to see the FDA approval of NERLYNX for the
treatment of advanced HER2-positive metastatic breast cancer. This
approval is based on data from the NALA trial, which we presented
at ASCO last year, demonstrating that neratinib in combination with
capecitabine offers a significant improvement over currently
available therapies in this heavily pretreated patient population
and can be added to NERLYNX’s established role in the treatment of
early breast cancer.”
In the United States, NERLYNX is approved for the extended
adjuvant treatment of adult patients with early stage HER2-positive
breast cancer, following adjuvant trastuzumab-based therapy. In
Europe, NERLYNX is approved for the extended adjuvant treatment of
adult patients with early stage hormone receptor-positive
HER2-overexpressed/amplified breast cancer and who are less than
one year from completion of prior adjuvant trastuzumab-based
therapy. NERLYNX has also received approval for use in the extended
adjuvant setting in Canada, Australia, Hong Kong, Singapore and
Argentina.
In collaboration with its global licensing partners, Puma
expects to seek approval of this second indication in all countries
where NERLYNX is currently approved.
About NALA
Efficacy of neratinib in combination with capecitabine was
investigated in NALA (NCT01808573), a randomized, multicenter,
open-label, Phase III clinical trial in 621 patients with
metastatic HER2-positive breast cancer who received two or more
prior anti-HER2-based regimens in the metastatic setting. Patients
were randomized (1:1) to receive neratinib 240 mg orally once daily
on days 1-21 in combination with capecitabine 750 mg/m2 given
orally twice daily on days 1-14 for each 21-day cycle (n=307) or
lapatinib 1250 mg orally once daily on days 1-21 in combination
with capecitabine 1000 mg/m2 given orally twice daily on days 1-14
for each 21-day cycle (n=314). Patients were treated until disease
progression or unacceptable toxicity. The trial was conducted
globally at sites in North America, Europe, Israel, Asia-Pacific
and South America.
The main efficacy outcome measures were progression-free
survival (PFS) as assessed by a blinded independent central review
per RECIST v1.1 and overall survival (OS). Key secondary outcome
measures were objective response rate (ORR) and duration of
response (DOR). Treatment with neratinib in combination with
capecitabine resulted in a statistically significant improvement in
PFS (Hazard Ratio 0.76; 95% CI: 0.63, 0.93; p=0.0059) compared to
treatment with lapatinib plus capecitabine. The PFS rate at 12
months was 29% (95% CI: 23, 35) for patients who received neratinib
plus capecitabine vs 15% (95% CI: 10, 20) for patients who received
lapatinib plus capecitabine; the PFS rate at 24 months was 12% (95%
CI: 7, 18) vs 3% (95% CI: 1, 8), respectively.
Median OS was 21 months (95% CI: 17.7, 23.8) for patients who
received neratinib in combination with capecitabine compared to
18.7 months (95% CI: 15.5, 21.2) for patients who received
lapatinib in combination plus capecitabine (HR 0.88; 95% CI: 0.72,
1.07; p=0.2086). The ORR was 32.8% (95% CI: 27.1, 38.9) vs 26.7%
(95% CI: 21.5, 32.4), respectively. Median duration of response was
8.5 months (95% CI: 5.6, 11.2) vs 5.6 months (95% CI: 4.2, 6.4),
respectively.
The most common adverse reactions of any grade (>5%) in the
neratinib plus capecitabine arm were diarrhea, nausea, vomiting,
decreased appetite, constipation, fatigue/asthenia, weight
decreased, dizziness, back pain, arthralgia, urinary tract
infection, upper respiratory tract infection, abdominal distention,
renal impairment, and muscle spasms. The most frequently reported
Grade 3 or 4 adverse reactions were diarrhea, nausea, vomiting,
fatigue and decreased appetite.
The recommended neratinib dose for advanced or metastatic breast
cancer is 240 mg (6 tablets) given orally once daily with food on
days 1-21 of a 21-day cycle plus capecitabine (750 mg/m2 given
orally twice daily) on days 1-14 of a 21-day cycle until disease
progression or unacceptable toxicities.
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.
IMPORTANT SAFETY INFORMATION
NERLYNX® (neratinib) tablets, for oral use
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor
indicated:
- As a single agent, for the extended adjuvant treatment of adult
patients with early-stage HER2-positive breast cancer, to follow
adjuvant trastuzumab-based therapy.
- In combination with capecitabine, for the treatment of adult
patients with advanced or metastatic HER2-positive breast cancer,
who have received two or more prior anti-HER2 based regimens in the
metastatic setting.
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Aggressively manage diarrhea. If diarrhea
occurs despite recommended prophylaxis, treat 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 (reported in ≥ 5% of patients)
were as follows:
- NERLYNX as a single agent: Diarrhea, nausea, abdominal pain,
fatigue, vomiting, rash, stomatitis, decreased appetite, muscle
spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin,
abdominal distention, epistaxis, weight decreased, , and urinary
tract infection.
- NERLYNX in combination with capecitabine: Diarrhea, nausea,
vomiting, decreased appetite, constipation, fatigue/asthenia,
weight decreased, dizziness, back pain, arthralgia, urinary tract
infection, upper respiratory tract infection, abdominal distention,
renal impairment, and muscle spasms.
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. When patients require gastric acid reducing
agents, use an H2-receptor antagonist or antacid. Separate NERLYNX
by at least 3 hours with antacids. Separate NERLYNX by at least 2
hours before or 10 hours after H2-receptor antagonists.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- Moderate CYP3A4 and P-glycoprotein (P-gp) dual 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 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.
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 PB272 (neratinib,
oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral
was approved by the U.S. Food and Drug Administration in 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 in 2018 for the extended
adjuvant treatment of adult patients with early stage hormone
receptor-positive HER2-overexpressed/amplified breast cancer and
who are less than one year from completion of prior adjuvant
trastuzumab-based therapy. NERLYNX is a registered trademark of
Puma Biotechnology, Inc.
Forward-Looking Statements
This news release includes forward-looking statements. All
forward-looking statements involve risks and uncertainties that
could cause 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, once filed, Puma’s Annual Report on Form 10-K for the
year ended December 31, 2019. 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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version on businesswire.com: https://www.businesswire.com/news/home/20200226005248/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com
David Schull or Maggie Beller, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
maggie.beller@russopartnersllc.com
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