FDA Approves NDA for Neratinib Along With Capecitabine for Metastatic Breast Cancer

“I am pleased to see the FDA approval of Nerlynx for the treatment of advanced HER2-positive metastatic breast cancer.”

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The U.S. Food and Drug Administration (FDA) announced the approval of a supplemental new drug application (sNDA) for neratinib (Nerlynx) in combination with capecitabine (Xeloda) for the treatment of advanced/metastatic HER2-positive breast cancer.

Puma Biotechnology, the developer of neratinib, announced that the FDA approved sNDA for the drug with capecitabine for adult patients with metastatic breast cancer who received at least 2 prior anti-HER2-based treatment in the metastatic setting.

A clinical trial was conducted globally at centers in North America, south American, Europe, Israel, and Asia-Pacific, which showed the drug’s safety and efficacy in treating advanced breast cancer.

Dr. Adam Brufsky of Magee-Women’s Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center said, “Together with the NALA investigators around the world, I am pleased to see the FDA approval of Nerlynx for the treatment of advanced HER2-positive metastatic breast cancer.”

“This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to Nerlynx’s established role in the treatment of early breast cancer,” he added.

The trial showed that treatment with neratinib in combination with capecitabine had a statistically significant improvement in progression-free survival (PFS) than treatment with lapatinib and capecitabine. The median overall survival rate also improved with neratinib and capecitabine.

Some of the most common side effects with neratinib and capecitabine include nausea, vomiting, decreased appetite, diarrhea, constipation, fatigue, loss of weight, dizziness, backache, joint pain, urinary tract infection, abdominal distention, renal impairment, and muscle spasms.

The recommended dose of neratinib for advanced/metastatic breast cancer is 240 mg given orally once a day, with food on days 1-21 of a 21-day cycle plus capecitabine.

CEO and president of Puma Biotechnology Alan Auerbach said, “Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress. Based on the results of our NALA data, we believe Nerlynx could be a promising therapeutic opportunity for these patients.”

In the United States, neratinib has already been approved for the extended adjuvant treatment of early-stage HER2-positive breast cancer. It is also approved in combination with trastuzumab (Herceptin).

In Europe, neratinib has been approved for the extended adjuvant treatment of early-stage HR-positive, HER2-overexpressed or amplified breast cancer.

The drug has also received approval for use in Australia, Canada, Hong Kong, Singapore, and Argentina. Puma Biotechnology is expecting approval of the drug’s second indication in all countries.