FDA Approves Puma Biotechnology’s Extended Adjuvant Therapy for Breast Cancer

Puma Biotechnology’s breast cancer drug Nerlynx (neratinib) has been approved by the US Food and Drug Administration (FDA). As an extended adjuvant therapy, the drug is designed to help prevent disease recurrence in patients with HER2-positive breast cancer.

“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,” Dr. 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 in a statement about the approval. “Now, these patients have an option after initial treatment that may help keep the cancer from coming back.”

Nerlynx is being touted as the first FDA-approved extended adjuvant therapy for this patient group. Patients previously treated with a chemotherapy regimen including trastuzumab may be eligible for treatment with Nerlynx.

As the most common type of cancer in the US, breast cancer is forecasted to affect 250,000 women this year, with over 40,000 of them dying as a result, according to the National Cancer Institute. Approximately 15 percent of these newly-diagnosed patients will have HER2-positive tumors.

Nerlynx is a tyrosine kinase inhibitor which is administered orally on a daily basis. Puma expects that the drug will become commercially available in September 2017.

“The 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,” said Dr. Marisa C. Weiss, Chief Medical Officer and Founder of Breastcancer.org, in a press release issued by Puma. “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.”

The FDA based their approval on a Phase III clinical trial involving 2,840 women with early-stage HER2-positive breast cancer. Two years after being treated with Nerlynx, 94.2 percent of patients had not experienced cancer recurrence or death, compared with 91.9 percent of placebo patients. While the numbers were close, the percentage of patients who experienced disease-free survival after receiving Nerlynx was statistically significant compared to the placebo group.

“Despite advances in the treatment of early stage HER2-positive breast cancer, there remains a need for further therapeutic improvements in order to attempt to further reduce the risk of disease recurrence,” said Alan H. Auerbach, CEO and President of Puma Biotechnology. “We are pleased to be able to bring this new medicine to patients with breast cancer.”