Patients with HER2 breast cancer will have a new treatment option available later this year, following the US Food and Drug Administration's (FDA) approval of the first extended adjuvant treatment for the condition. Nerlynx (neratinib), a kinase inhibitor from Puma Biotechnology, was granted FDA approval for treating adult patients with early-stage HER2 breast cancer to follow adjuvant trastuzumab-based therapy.
Puma Biotechnology expects the new drug to be available in US pharmacies in September 2017. Approval was granted following a Phase III ExteNET trial, which demonstrated a 94.2 percent rate of invasive disease-free survival in patients treated with neratinib after two years of follow up, compared with 91.9 percent in patients given a placebo.
"New and effective innovative therapeutic options provide huge hope to patients and their families, giving them a better chance of overcoming breast cancer with a chance for a full life," said Marisa C Weiss, MD, chief medical officer and founder of Breastcancer.org. "Fear of recurrence is ever present in the minds of most women with breast cancer, from the moment they are diagnosed to long after they finish adjuvant treatment," she asserted.
Nerlynx is a once-daily oral tyrosine kinase inhibitor, with a recommended dose of 240mg (six 40mg tablets), which patients should take continually for one year. It is indicated for the extended adjuvant treatment of adult patients diagnosed with early-stage HER2 overexpressed/amplified breast cancer to follow adjuvant therapy using trastuzumab.
Puma Biotechnology expects the new drug to be available in US pharmacies in September 2017. Approval was granted following a Phase III ExteNET trial, which demonstrated a 94.2 percent rate of invasive disease-free survival in patents treated with neratinib after two years of follow up, compared with 91.9 percent in patients given a placebo.
Common Side Effects of Nerlynx
The most common adverse reactions to the drug in the trials were diarrhea, nausea, abdominal pain, vomiting, fatigue, stomatitis, rash, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection.
Diarrhea was the most common side effect, observed in nearly 17 percent of the neratinib-treated patients in the trial. Patients may need to take loperamide to manage diarrhea during the first 56 days of taking Nerlynx, according to Puma Biotechnology.
About HER2 Breast Cancer
Breast cancer is the most common form of cancer in the US, affecting approximately 250,000 women each year, according to the National Cancer Institute (NCI). The NCI estimates approximately 15 pence of patients with the disease have tumors that are HER2 positive.
HER2 breast cancer is an aggressive form of the disease, although research has shown patients with the condition respond well to trastuzumab treatment, for example using Herceptin (trastuzumab). This reduces the risk of early stage HER2 positive breast cancer returning following surgery, yet up to 25 percent of patients still experience recurrence. Other drugs used to treat breast cancer include Kadcyla (ado-trastuzumab emtansine) and Taxotere (docetaxel).
Richard Pazdur, MD, 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, stated: "HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan." He added the latest FDA approval provides patients with an option to help prevent the return of cancer after their initial treatment.
For more information on Nerlynx, visit the link below.