Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer
2023年9月22日 - 5:10AM
ビジネスワイヤ(英語)
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical
company, announced that the U.S. Food and Drug Administration (FDA)
has granted Orphan Drug Designation to alisertib, a selective,
small-molecule, orally administered inhibitor of aurora kinase A,
for the treatment of patients with small cell lung cancer (SCLC).
SCLC is an aggressive form of lung cancer with a poor prognosis,
and with limited treatment options for patients whose cancer has
progressed on or after platinum-based chemotherapy.
“Obtaining Orphan Drug Designation from the FDA signifies our
continued progress and commitment to the development of alisertib
for the treatment of small cell lung cancer,” said Alan H.
Auerbach, Chief Executive Officer, President and Founder of Puma.
“There is an urgent need for new treatments for patients with small
cell lung cancer, and we look forward to the initiation of our
Phase II trial (Study PUMA-ALI-4201) of alisertib in small cell
lung cancer.”
The FDA grants Orphan Drug Designation to investigational
therapies being developed to treat, diagnose or prevent a rare
disease or condition affecting fewer than 200,000 people in the
United States. Further, Orphan Drug Designation provides benefits
to drug developers, including assistance in the drug development
process, tax credits for qualified trials, waiver of certain FDA
fees, and the potential for seven years of post-approval marketing
exclusivity.
Puma received FDA clearance of its Investigational New Drug
application for the clinical development of alisertib monotherapy
for the treatment of patients with extensive stage SCLC in August
2023 and anticipates initiating the Phase II trial in the second
half of 2023.
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), 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. 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.
Further information about Puma Biotechnology may be found at
https://www.pumabiotechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements regarding the development and
commercialization of alisertib. All 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
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 Puma’s Annual
Report on Form 10-K for the year ended December 31, 2022 and
subsequent reports. 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/20230921760363/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc.,
+1 424 248 6500 info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull, +1 212 845 4200
david.schull@russopartnersllc.com
Puma Biotechnology (NASDAQ:PBYI)
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