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Puma’s Nerlynx approved as extended adjuvant breast cancer therapy

By Jennifer Boggs, Managing Editor

Despite some skepticism heading toward the July 21 PDUFA date, Puma Biotechnology Inc.’s breast cancer drug, Nerlynx (neratinib), won FDA approval a few days early, marking the first treatment designated as an extended adjuvant therapy in patients with early stage, HER2-positive disease.

Nerlynx, an oral, irreversible tyrosine kinase inhibitor, is designed to be taken after initial treatment to further lower the risk of the cancer recurring. It is indicated for adults who have been previously treated with a regimen including HER2-targeting trastuzumab.

Approval followed the 12-4 vote in May by the FDA’s Oncologic Drugs Advisory Committee, during a half-day meeting in which committee members expressed mixed opinions regarding the proposed label for Nerlynx. (See BioWorld Today, May 25, 2017.)

Nerlynx’s submission was based on data from the randomized ExteNET study involving 2,840 patients with early stage, HER2-positive breast cancer who had completed trastuzumab treatment within the prior two years. After two years, 94.2 percent of patients treated with Nerlynx had not experienced cancer recurrence of death, compared to 91.9 percent of patients receiving placebo.

Common side effects include nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, indigestion, liver damage, abdominal swelling, weight loss and urinary tract infection. One of the most troublesome side effects, diarrhea, was mitigated in trials with the use of loperamide. The drug’s label calls for patients to receive loperamide for the first 56 days of treatment with Nerlynx and as needed thereafter to help manage rates of diarrhea. (See BioWorld Today, Dec. 28, 2015.)

According to the National Cancer Institute, about 252,710 women in the U.S. will be diagnosed with breast cancer this year. Of those, roughly 15 percent have tumors that are HER2-positive.

Shares of Los Angeles-based Puma (NASDAQ:PBYI) were halted just prior to news of the approval late Monday afternoon. The stock closed at $86.10, down $3.45.