publication date: Aug. 3, 2017

Regulatory Actions

FDA approves treatment to reduce risk of breast cancer returning

FDA approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.

The FDA granted the approval of Nerlynx to Puma Biotechnology Inc.

Nerlynx is a kinase inhibitor that works by blocking several enzymes that promote cell growth. The safety and efficacy of Nerlynx were studied in a randomized trial of 2,840 patients with early-stage, HER2-positive breast cancer who completed treatment with trastuzumab within the previous two years.

The study measured the amount of time after the start of the trial that it took for the cancer to come back or for death to occur from any cause (invasive, disease-free survival).
After two years, 94.2 percent of patients treated with Nerlynx had not experienced cancer recurrence or death, compared with 91.9 percent of patients receiving placebo.

Common side effects of Nerlynx include diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, swollen and sore mouth (stomatitis), decreased appetite, muscle spasms, indigestion (dyspepsia), liver damage (AST or ALT enzyme increase), nail disorder, dry skin, abdominal swelling (distention), weight loss and urinary tract infection.

FDA converts accelerated approval of Amgen’s Blincyto to full approval in ALL

FDA has approved the supplemental Biologics License Application for Blincyto (blinatumomab) to include overall survival data from the phase III TOWER study.

The approval converts Blincyto’s accelerated approval to a full approval. The sBLA approval also included data from the … Continue reading CCL July 2017 – FDA approves treatment to reduce risk of breast cancer returning

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