FDA Supports Use of Anti-diarrheal Medications with Nerlynx

FDA Supports Use of Anti-diarrheal Medications with Nerlynx
The U.S. label of Nerlynx (neratinib), a treatment for early stage HER2-positive breast cancer, now includes information on the use of two anti-diarrheal medications to prevent severe side effects of the therapy. Puma Biotechnology, which markets Nerlynx, received approval from the U.S. Food and Drug Administration (FDA) to include a label supplement about the use of loperamide (brand name Imodium A-D, among others) and budesonide (sold as Entocort, among other names) to reduce Nerlynx-associated diarrhea. The supplement approval was based on preliminary findings from the ongoing CONTROL Phase 2 trial (NCT02400476), which was designed to evaluate the efficacy of anti-diarrheal medicines in patients with early-stage HER2-positive breast cancer receiving Nerlynx. While Nerlynx significantly delayed the time to invasive disease or death in a prior trial (NCT00878709) — leading to its approval — nearly all patients (95.4%) experienced diarrhea as a side effect of the treatment, and more than one-third (39.8%) had severe diarrhea. This adverse effect lasted five days on average and was the reason for stop
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