Puma’s neratinib AdCom unlikely to be thwarted by Roche’s APHINITY win; ER+ niche may find takers but an uphill task – experts

12 May 2017

Puma Biotechnology's (NASDAQ:PBYI) neratinib FDA advisory committee (AdCom) review and approval chances in the extended adjuvant setting will unlikely be impacted by Roche's (VTX:ROG) Phase III Perjeta (pertuzumab) data in the adjuvant setting for Her2+ breast cancer, said experts.

However, during the 24 May AdCom review, Puma will face questions on data integrity of its Phase III pivotal ExteNET study (NCT02400476), since the trial design was changed through the course of the study and because of its Grade 3 diarrhea side-effect profile, said experts.

Following Roche's 2 March announcement that the addition of Perjeta to Roche's Herceptin (trastuzumab) and chemotherapy was an improvement over Herceptin/chemotherapy, the market was speculating this news would invalidate neratinib's study as an extended adjuvant treatment (neratinib after one year of Herceptin/chemotherapy). Experts this news service spoke to, however, said the news would likely have minimal impact on neratinib's regulatory discussions but would impact the drug's potential usage.

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