Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced that the National Comprehensive Cancer Network
(NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
for Cervical Cancer were updated to include an addition involving
neratinib (NERLYNX®).
The updated NCCN Practice Guidelines for Cervical Cancer include
neratinib monotherapy for use as second-line or subsequent therapy
for recurrent or metastatic disease as an option for patients with
HER2-mutated tumors with a designation of Category 2A. The NCCN
Guidelines Category of Preference is designated as “useful in
certain circumstances” as a treatment option for patients with
HER2-mutated tumors.
This addition was based on results from the Phase II SUMMIT
trial (NCT01953926), which enrolled a cohort of patients who were
required to have histologically confirmed recurrent/metastatic
cervical cancer for which no curative treatment existed, along with
documented evidence of a somatic, activating HER2 mutation
(Friedman CF, D'Souza A, Bello Roufai D, et al. Targeting
HER2-mutant metastatic cervical cancer with neratinib: Final
results from the Phase II SUMMIT basket trial. Gynecol Oncol.
2024;181:162-169. doi: 10.1016/j.ygyno.2023.12.004).
Alan H. Auerbach, Chief Executive Officer and President of Puma,
said, “We are pleased with the additional inclusion of neratinib in
the NCCN Guidelines for Cervical Cancer for patients with HER2
activating mutations. Physicians use the NCCN Guidelines as the
standard resource for determining the best course of treatment for
patients. We believe the updated NCCN guidelines will increase
awareness, which will help assist patients, their caregivers and
their healthcare providers in making informed decisions while
treating this significant unmet need in advanced cervical
cancer.”
About HER2-Mutated Cervical Cancer
Despite recent advancements in the therapeutic landscape for
recurrent and metastatic cervical cancer, there is a need to
identify robust biomarkers to direct therapy choices to target
mutational drivers. Somatic HER2 (ERBB2) mutations have been
reported in up to 9% 1,2,3 of cervical cancers and are associated
with poor prognosis 1,2. In a recent real-world study, prospective
genomic profiling of cervical cancer patients identified HER2
mutations as one of the more prevalent genomic alterations in the
studied cervical cancer population3.
About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network® (NCCN®) is a
not-for-profit alliance of leading cancer centers devoted to
patient care, research, and education. NCCN is dedicated to
improving and facilitating quality, effective, efficient, and
accessible cancer care so patients can live better lives. The NCCN
Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide
transparent, evidence-based, expert consensus recommendations for
cancer treatment, prevention, and supportive services; they are the
recognized standard for clinical direction and policy in cancer
management and the most thorough and frequently updated clinical
practice guidelines available in any area of medicine. The NCCN
Guidelines for Patients® provide expert cancer treatment
information to inform and empower patients and caregivers, through
support from the NCCN Foundation®. NCCN also advances continuing
education, global initiatives, policy, and research collaboration
and publication in oncology. Visit NCCN.org for more
information.
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-licensed the global
development and commercialization rights to PB272 (neratinib,
oral), in 2011. 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. In
February 2020, NERLYNX was also approved by the FDA 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.
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.
In September 2022, Puma entered into an exclusive license
agreement for the development and commercialization of the
anti-cancer drug alisertib, a selective, small molecule, orally
administered inhibitor of aurora kinase A. Initially, Puma intends
to focus the development of alisertib on the treatment of small
cell lung cancer and breast cancer. In February 2024, Puma
initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib
monotherapy for the treatment of patients with extensive-stage
small cell lung cancer. In November 2024, Puma initiated
ALISCA™-Breast1, a Phase II clinical trial of alisertib in
combination with endocrine therapy for the treatment of patients
with HER2-negative, HR-positive metastatic breast cancer.
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
https://www.NERLYNX.com or by dialing 1-855-816-5421.
Further information about Puma Biotechnology may be found at
https://www.pumabiotechnology.com.
INDICATIONS
- NERLYNX® (neratinib) tablets, for oral use, 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.
Important Safety Information Regarding NERLYNX® (neratinib)
U.S. Indication
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
- Diarrhea: Manage diarrhea through either NERLYNX dose
escalation or loperamide prophylaxis. 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) 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. Separate NERLYNX by at least 2 hours before or 10
hours after H2-receptor antagonists. Or separate NERLYNX by at
least 3 hours with antacids.
- Strong CYP3A4 inhibitors: Avoid concomitant use.
- P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant
use.
- Strong or moderate CYP3A4 inducers: Avoid concomitant use.
- Certain P-gp substrates: Monitor for adverse reactions of P-gp
substrates for which minimal concentration change may lead to
serious adverse reactions when used concomitantly with
NERLYNX.
USE IN SPECIFIC POPULATIONS:
- Lactation: Advise women not to breastfeed.
Please see Full Prescribing Information for additional safety
information.
1 Xiang L, Jiang W, Ye S, He T, Pei X, Li J, et al. ERBB2
mutation: A promising target in non-squamous cervical cancer.
Gynecol Oncol. 2018;148(2):311-316.
2 Zammataro L, Lopez S, Bellone S, Pettinella F, Bonazzoli E,
Perrone E, et al. Whole-exome sequencing of cervical carcinomas
identifies activating ERBB2 and PIK3CA mutations as targets for
combination therapy. Proc Natl Acad Sci U S A.
2019;116(45):22730-22736.
3 Friedman CF, Ravichandran V, Miller K, et al. Assessing the
genomic landscape of cervical cancers: clinical opportunities and
therapeutic targets. Clin Cancer Res. 2023;29(22):4660-4668. doi:
10.1158/1078-0432.CCR-23-1078. PMID: 37643132; PMCID:
PMC10644000.
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version on businesswire.com: https://www.businesswire.com/news/home/20241223490944/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Olipriya Das, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
Puma Biotechnology (NASDAQ:PBYI)
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Puma Biotechnology (NASDAQ:PBYI)
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