Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer
- Orphan Drug Designation provides benefits to drug developers, including assistance in the drug development process, tax credits, and potential marketing exclusivity
- None.
“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
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
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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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
Source: Puma Biotechnology, Inc.