July 18, 2017
By Alex Keown, BioSpace.com Breaking News Staff
LOS ANGELES – Shares of Puma Biotechnology are up nearly 12 percent this morning after the U.S. Food and Drug Administration (FDA) approved the company’s breast cancer drug, Nerlynx (neratinib).
Nerlynx, formerly known as PB272, received support of a FDA advisory committee in May, which recommended approval in a 12-4 vote. Dissenting members in May expressed concern over some of the risks associated with the drug, particularly severe diarrhea. During clinical trials, approximately 40 percent of patients who took the drug suffered a severe form of diarrhea, although about 95 percent of patients who took the drug had some form of diarrhea. Incidents of grade 3 diarrhea were single-episode events, with episodes restricted to the first cycle of therapy.
On Monday though, the FDA gave full support to the drug, which is used for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. HER2-positive breast cancer is an aggressive form of the disease, which affects approximately one in five people with breast cancer and is associated with a poor prognosis if left untreated. To cope with issues of diarrhea, the FDA said patients should be given loperamide for the first 56 days of treatment with Nerlynx and as needed thereafter to help manage diarrhea.
In a statement issued Monday, Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said the severity of HER2-positive breast cancer makes adjuvant therapy an important part of the treatment plan. With Nerlynx, Pazdur said patients “have an option after initial treatment that may help keep the cancer from coming back.”
Marisa C. Weiss, Breastcaner.org’s founder and chief medical officer, agreed about patients’ concerns over breast cancer returning. She said that fear is “ever present” in patients “from the moment they are diagnosed to long after they finish adjuvant treatment.”
Extended adjuvant treatment for breast cancer is important, as about one-third of people treated with a drug like Roche ’s Herceptin and chemotherapy may eventually see their cancer return. This is the first extended adjuvant therapy of its kind approved by the FDA.
The FDA’s approval was based on data from the Phase III ExterNET trial that showed treatment with Nerlynx resulted in a 33 percent reduction of risk of invasive disease recurrence or death versus placebo. During clinical trials Nerlynx, a potent tyrosine kinase inhibitor, demonstrated a disease-free survival (DFS) rate of 94.2 percent compared with 91.6 percent in the placebo group.
Puma has not released information on what it will charge for Nerlynx and did not indicate when it might make that announcement. Some analysts have pegged Nerlynx to bring in about $1.5 billion in annual revenue for Puma. If the drug does begin to generate that kind of revenue, it could spur additional speculation that Puma will be acquired by an M&A hungry company.
Shares of Puma hit a morning high of $95.22 as of 9:35 a.m.
