Puma Biotechnology Presents Updated Findings from the TBCRC-022 Trial at the 2022 San Antonio Breast Cancer Symposium
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, today announced an agreement with Takeda to license the worldwide research and development and commercial rights to alisertib, a selective, small-molecule, orally administered inhibitor of aurora kinase A. Alisertib is an adenosine triphosphate–competitive and reversible inhibitor of aurora kinase A and results in disruption of mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Alisertib has been tested in clinical trials in patients with metastatic cancers including breast cancer, small cell lung cancer, head and neck cancer, ovarian cancer, peripheral T cell lymphoma and acute myeloid leukemia.
Sandoz B2B Generic Neratinib Maleate Receives Approval in the U.S.
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented final results from the Phase II SUMMIT ‘basket’ trial, assessing the efficacy of neratinib in treatment-refractory patients with metastatic biliary tract cancers with somatic HER2 mutations at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation entitled “Targeting HER2 mutation-positive advanced biliary tract cancers with neratinib: Final results from the phase 2 SUMMIT ‘basket’ trial” was presented at the Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Poster Session (#4079) by James J. Harding, MD, Regional Director, Early Drug Development, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College, an investigator of the trial. A copy of this poster presentation is available on the Puma website.
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of breast cancer have been updated for 2022 and include two important changes involving neratinib (NERLYNX®).
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced that the United States Patent and Trademark Office (USPTO) issued a Patent Term Extension Certificate for U.S. Patent No. 7,399,865, extending the patent term five (5) years. The patent includes composition of matter claims for NERLYNX® and will now expire on December 29, 2030. The patent term extension is pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984, also referred to as the Hatch-Waxman Amendments, which permits an extension of the term of one patent for a maximum period of five years.
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced the release of 9 abstracts that will be presented at the 2021 San Antonio Breast Cancer Symposium (SABCS), to be held at the Henry B. Gonzalez Convention Center in San Antonio, Texas, from December 7-10, 2021. Abstracts are available to the public online on the SABCS website at www.sabcs.org.
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented interim results from the ongoing SUMMIT trial of neratinib in the cohort of metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor (EGFR) exon 18 mutations who have been previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI). The data were presented in an oral discussion at the 2020 World Conference on Lung Cancer (WCLC 2020) presented by the International Association for the Study of Lung Cancer (IASLC) that is currently taking place in Singapore. The presentation, entitled, “Neratinib in Pretreated EGFR Exon 18-Mutated Non-Small Cell Lung Cancer (NSCLC): Initial Findings from the SUMMIT Basket Trial,” is being presented at an Oral Session by Valentina Boni, MD, PhD, START Madrid-CIOCC, Centro Oncologico Clara Campal, HM Sanchinarro.