Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, and Strata Oncology, Inc., a precision oncology company,
have entered into a collaborative agreement to accelerate patient
enrollment in Puma’s ongoing Phase II SUMMIT trial of PB272
(neratinib). The SUMMIT trial is a global, multi-histology,
open-label, precision-medicine ‘basket’ study evaluating the safety
and efficacy of neratinib in patients with a wide variety of solid
tumors with activating EGFR, HER2 or HER4 mutations.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20180717005971/en/
Neratinib, an oral irreversible pan-HER kinase inhibitor, was
approved by the FDA in July 2017 for the extended adjuvant
treatment of adult patients with early stage HER2-positive breast
cancer following adjuvant trastuzumab-based therapy and is marketed
in the United States as NERLYNX®. Data published in the journal
Nature earlier this year showed neratinib has activity across
multiple tumor types with HER2-activating mutations.
Under the terms of the agreement, Strata will exclusively refer
HER2-mutated advanced cancer patients identified through the Strata
Trial for consideration of enrollment to Puma’s SUMMIT Trial for
neratinib.
The Strata Trial is a screening protocol providing comprehensive
tumor molecular profiling to advanced cancer patients at no cost
and proactive enrollment support for a portfolio of
pharma-sponsored precision therapy trials. Tumor profiling through
the Strata Trial is provided as part of routine care to solid tumor
patients across the Strata Precision Oncology Network, a network of
11 leading health systems representing more than 85,000 new cancer
patients annually. This large network of trial-ready health systems
with fully pre-screened advanced cancer populations enables rapid
and predictable enrollment of precision therapy trials.
“We are pleased to partner with Puma Biotechnology to accelerate
the path to new approvals for neratinib,” said Dan Rhodes, Ph.D.,
CEO of Strata Oncology. “We frequently identify HER2-mutant
patients across the Strata Precision Oncology Network and we
believe this partnership will greatly facilitate patient access to
this promising clinical trial.”
“Puma’s ultimate goal is to deliver new treatment options and
improve the lives of patients with various types of cancer,” said
Alshad S. Lalani, V.P., Translational Medicine of Puma
Biotechnology. “We believe Puma’s partnership with Strata will help
us reach patients with multiple tumor types who may not otherwise
know about the SUMMIT study, giving them a chance to participate in
research that’s designed to provide important new information for
future treatment.”
About Strata Oncology
Strata Oncology is a precision medicine company dedicated to
transforming cancer care by systematizing precision oncology across
a network of health systems and pharma companies. We empower
health systems to deliver a cost-effective, system-wide precision
oncology program, one that integrates cutting-edge molecular
profiling and precision therapy trials with routine care, so that
all advanced cancer patients have the opportunity to
benefit. This large network of trial-ready health systems
provides a mechanism to rapidly and predictably enroll precision
therapy trials. For more information,
visit www.strataoncology.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 is a registered trademark of Puma Biotechnology, Inc.
Important Safety Information (ISI)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 expected benefits from the
collaboration between Puma and Strata. All statements other than
historical facts are forward–looking statements and are based on
Puma’s current expectations, forecasts and assumptions.
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 risk and uncertainties are
identified in Puma’s filings with the Securities and Exchange
Commission, including its 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20180717005971/en/
Puma Biotechnology, Inc.Alan H. Auerbach or Mariann Ohanesian,
+1 424 248
6500info@pumabiotechnology.comir@pumabiotechnology.comorStrata
Oncology Media Relations, +1 734 527
1000media@strataoncology.comorRusso PartnersDavid Schull or Amiad
Finkelthal, +1 212 845
4200david.schull@russopartnersllc.comamiad.finkelthal@russopartnersllc.com
Puma Biotechnology (NASDAQ:PBYI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Puma Biotechnology (NASDAQ:PBYI)
Historical Stock Chart
From Apr 2023 to Apr 2024