Puma Biotechnology +13% after FDA OKs Nerlynx label addition

Puma Biotechnology (NASDAQ:PBYI) surges 13% in after-hours trading after the U.S. Food and Drug Administration approves a labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer.

With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reduction of neratinib-associated diarrhea that has a primary endpoint of the incidence of grade 3 or higher diarrhea.

Interim data from the trial showed that the addition of prophylactic treatment with loperamide and budesonide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.’

Neratinib was approved by the FDA in July 2017 for extended adjuvant treatment for adult patients with early stage HER2-positive breast cancer.

https://seekingalpha.com/news/3503593-puma-biotechnology-plus-13-percent-fda-oks-nerlynx-label-addition