Neratinib

[beachgirl501]

Does anyone know anything about phase III drug Neratinib and when/if it will be approved? What about side effects? Thanks.

[Heathcliff4]

Nancy,

I am watching this closely with my doc at UCSF. The company was hoping to have approval for it in early 2015 but it was pushed back as the FDA wants them to do more animal testing for secondary cancers. She expects a year delay. My breast oncologist (who's husband is a breast oncology researcher at UCSF as well and knows Puma Biotech well) thinks it's an outrageous demand at this stage in the drugs history.

My understanding is that if administered as a single agent, the most common side effect is diarrhea.

I will keep you updated when I know more. I meet w. her in a few months and we are going to discuss its use. Also, initially, they were saying that you need to introduce Neratinib within 3 months of being on Herceptin. That may no longer be there case.

Kathryn
8/13 dx her2+++, pr+, er+, stage 2a, right breast 3 lymph nodes
9/13 bilateralmastectomy
10/13 - 2/14 ac/th, herceptin and perjeta
3/14 6 2weeks radiation
6/14 tamoxifen, tried it and stopped, terrible side effects
7/14 arimidex, tried it. currently taking vacation
exchange surgery scheduled 1/15

[Jackie07]

Curr Cancer Drug Targets. 2014 Nov 10. [Epub ahead of print]
Irreversible Multitargeted ErbB Family Inhibitors for Therapy of Lung and Breast Cancer.
Subramaniam D, He AR, Hwang J, Deeken J, Pishvaian M, Hartley ML, Marshall JL1.
Author information
Abstract
Overactivation of the ErbB protein family, which is comprised of 4 receptor tyrosine kinase members (ErbB1/epidermal growth factor receptor [EGFR]/HER1, ErbB2/HER2, ErbB3/HER3, and ErbB4/HER4), can drive the development and progression of a wide variety of malignancies, including colorectal, head and neck, and certain non-small cell lung cancers (NSCLCs). As a result, agents that target a specific member of the ErbB family have been developed for the treatment of cancer. These agents include the reversible EGFR tyrosine kinase inhibitors (TKIs) erlotinib and gefitinib; the EGFR-targeting monoclonal antibodies cetuximab and panitumumab; and the HER2-targeting monoclonal antibody trastuzumab. Lapatinib is a dual TKI that targets both EGFR and HER2. In addition, TKIs that inhibit multiple members of the ErbB family and also bind their targets irreversibly are under evaluation for the treatment of cancer. Three such compounds have progressed into clinical studies: the EGFR, HER2, and HER4 inhibitors afatinib, dacomitinib, and neratinib. Phase I studies of these agents have shown clinical activity in NSCLC, breast cancer, and other malignancies. Currently, afatinib is approved for EGFR mutation-positive NSCLC and is in development for squamous NSCLC and dacomitinib is in phase III of clinical development for NSCLC, neratinib is in phase III of clinical development for the treatment of breast cancer, and afatinib is also in phase III development in head and neck cancer. Final results from clinical trials may lead to the potential approval of these agents in a variety of solid tumor malignancies.

[Jackie07]

Looks like (If I'd read it correctly) because the company had changed the trial to include early stagers, the result of Phase III trial won't be in until 2016.

http://www.nasdaq.com/article/puma-b...-blog-cm419632