Evidence Review

Puma's PB272 (neratinib) for Breast Cancer

PB272.pngTables in this report include:

  • Clinical trial experience of PB272 (neratinib) vs. Herceptin (trastuzumab) and Tykerb (lapatinib) 

  • Comparison of IME-Serious AEs from clinical trials and drug labels of PB272, Herceptin, and Tykerb

  • IME Serious RxSignals for Herceptin and Tykerb

Actionable Intelligence: PB272 (neratinib), currently under review by FDA, will likely be approved for the extended adjuvant treatment of HER2-positive early stage breast cancer. Aggregated serious adverse event rates were higher across all neratinib trials in the Evidex database compared to control groups (12.51% vs. 7.22%, respectively), and the highest incidence safety issues were gastrointestinal disorders including serious diarrhea (30.16% vs. 2.22% control).

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Please note: This is an independent analysis conducted by Advera Health, based upon data and insight generated by the analytical tools of Evidex and other pertinent information gathered at the time of publication. This analysis is not sponsored or influenced by any third party. The inclusion of a particular company, drug, adverse event, class or indication in this report is determined wholly by our quantitative signaling and analytic systems along with our qualitative analysis work.