Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 31, 2019

Neratinib

(Nerlynx—Puma Biotechnology)
Neratinib approved for extended adjuvant treatment of HER2-positive early stage breast cancer

Puma Biotechnology announced FDA approval of neratinib, a kinase inhibitor, for extended adjuvant treatment of HER2-positive early stage breast cancer, following adjuvant trastuzumab-based therapy.

In the ongoing Phase II CONTROL trial, patients with HER2-positive early stage breast cancer who have completed trastuzumab-based adjuvant therapy receive neratinib daily for 1 year. The trial initially tested high-dose loperamide prophylaxis given for the first two cycles (56 days) of treatment (12 mg on days 1–14, 8 mg on days 15–56, and as needed thereafter).

The CONTROL trial 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 with 32% in patients treated with loperamide alone. Diarrhea leading to treatment discontinuation declined to 11% in the loperamide plus budesonide cohort, compared with 18% in the loperamide alone cohort.

The most common adverse reactions (≥ 5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, decreased weight, decreased and urinary tract infection.