FDA approves extension of label for Nerlynx to include safety information for patients with HER2-positive early stage breast cancer.- Puma Biotechnology

Puma Biotechnology, Inc. announced that the FDA has approved 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 plus budesomide reduced the discontinuation rate due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.In the ongoing CONTROL Trial, patients with HER2-positive early stage breast cancer who have completed trastuzumab-based adjuvant therapy receive neratinib daily for a period of one year. The trial initially tested high dose loperamide prophylaxis given for the first 2 cycles (56 days) of treatment (12 mg on days 1-14, 8 mg on days 15-56 and as needed thereafter). The CONTROL Trial (NCT02400476) was then expanded to include four additional cohorts. One cohort received the combination of loperamide and budesonide. For the 64 patients who received the combination of loperamide plus budesonide, the incidence of grade 3 diarrhea was 28% compared to 32% in patients treated with loperamide alone. Diarrhea leading to treatment discontinuation declined to 11% in the loperamide plus budesonide cohort, compared to 18% in the loperamide alone cohort. Neratinib was approved by the FDA in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed in the United States as Nerlynx (neratinib) tablet.