The FDA has approved neratinib for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. The drug is a tyrosine kinase inhibitor similar to lapatinib and afatinib. Neratinib is indicated for adults who have been treated with a regimen that includes trastuzumab (Herceptin). The safety and efficacy of neratinib was established in a randomized trial of 2,840 patients with early-stage HER-2 positive breast cancer who had completed treatment with trastuzumab within the previous two years. After two years, invasive disease-free survival was 94.2% with neratinib compared to 91.9% with placebo. The drug commonly causes diarrhea, and loperamide should be administered routinely for the first eight weeks of therapy. Neratinib is marketed as Nerlynx.
The FDA has approved a new combination for the treatment of hepatitis C virus genotypes 1-6 in patients without cirrhosis or with mild cirrhosis. The fixed-dose combination contains two previously approved drugs, sofosbuvir and velpatasvir, along with a new drug, voxilaprevir. It is the first treatment for patients who have been treated with sofosbuvir or NS5A inhibitors. In two Phase III trials, the combination resulted in 96-97% cure rates (no virus detected at 12 weeks) in patients with all genotypes, some of whom had been treated previously. As with all hepatitis C treatment, patients must be screened for hepatitis B to avoid reactivation. The FDA granted this application priority review and breakthrough therapy designations. The new combination is marketed as Vosevi. The drug requires a 12-week course, which will cost about $75,000.
In this section: FDA approves new treatments for breast cancer and hepatitis C.
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