Acquisition & Development of cancer therapies

Puma Biotechnology focuses on developing innovative cancer therapies, particularly targeting HER2-positive breast cancer. Their flagship product, NERLYNX (neratinib), is the first FDA-approved treatment specifically designed for early-stage and metastatic HER2-positive breast cancer patients who have previously undergone trastuzumab-based therapy. NERLYNX can be administered alone or in combination with capecitabine for patients with metastatic disease who have received multiple anti-HER2 therapies. The drug works by inhibiting the HER2 receptor, which is often overexpressed in certain breast cancers, thereby helping to prevent cancer cell growth and proliferation.

In addition to NERLYNX, Puma Biotechnology is advancing its clinical pipeline with alisertib, an investigational drug targeting small cell lung cancer and metastatic breast cancer. The company has initiated several clinical trials, including the ALISCA™-Breast1 and ALISCA™-Lung1 trials, to evaluate the efficacy and safety of alisertib in these cancer types. Alisertib functions as an Aurora Kinase A inhibitor, which plays a crucial role in cell division and is implicated in cancer progression. Through these innovative therapies, Puma Biotechnology aims to improve treatment outcomes for patients with challenging cancer diagnoses.

United States

At Puma Biotechnology, our focus is on bringing innovative therapies to patients to enhance cancer care.

We are thankful to be part of the HER2+ breast cancer community and are passionate about evaluating options that may benefit patients across the breast cancer therapy spectrum. 

Cancer

Puma Biotechnology

Breast cancer

ER+/HER2- breast cancer

Solid tumor/s

Neratinib is an intracellular kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2, and HER4. In vitro, neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2, and HER4 in vitro. In vivo, oral administration of neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.

NERLYNX

Sexual desire disorder

Sexual dysfunction

Bile duct disease

Neratinib 

Lung cancer

Non-small cell lung carcinoma

Neratinib

Metastatic breast cancer

Metastatic breast cancer to brain

Neratinib (HKI-272) + fulvestrant + trastzuzumab 

Trastuzumab Emtansine (T-DM1) With Neratinib

Catheter related blood stream infections

Cervical cancer

Infectious disease

Neratinib is an intracellular kinase inhibitor that irreversibly binds to epidermal growth factor receptor (EGFR), HER2, and HER4. In vitro, neratinib reduces EGFR and HER2 autophosphorylation, downstream MAPK and AKT signaling pathways, and showed antitumor activity in EGFR and/or HER2 expressing carcinoma cell lines. Neratinib human metabolites M3, M6, M7 and M11 inhibited the activity of EGFR, HER2, and HER4 in vitro. In vivo, oral administration of neratinib inhibited tumor growth in mouse xenograft models with tumor cell lines expressing HER2 and EGFR.

Alisertib Inhibits Aurora Kinase A (AURKA), a serine/threonine protein kinase and transcription factor Leads to: – Disruption of mitotic spindle apparatus assembly – Disruption of chromosome segregation – Inhibition of cell proliferation Highly selective, reversible ATP competitive inhibitor.

Puma Biotechnology

Company Details