FDA Approves Nerlynx (Neratinib) for a type of Breast Cancer

Written By:Stacy Simon

The US Food and Drug Administration (FDA) has approved the first extended adjuvant therapy for early-stage, HER2-postive breast cancer. This type of drug is taken after initial treatment to lower the chances the cancer will come back. The new drug, Nerlynx (neratinib), is for women who have been previously treated with the targeted therapy drug Herceptin (trastuzumab).

Breast tumors with higher levels of a protein known as HER2 are called HER2-positive breast cancers. They tend to grow and spread faster than other breast cancers, and are more likely to come back after treatment. Therefore, a drug to help lower recurrence for this type of cancer is significant.

Nerlynx is a type of drug called a kinase inhibitor. It’s a kind of targeted therapy that blocks certain proteins in the cancer cells. Blocking them helps keep the cells from dividing, and that can slow cancer growth.

The FDA based its approval on a study of 2,840 women with HER2-positive breast cancer in stages 1 – 3. All had completed treatment with Herceptin within the previous 2 years. The study measured how long it took for the cancer to come back or for death to occur from any cause. After 2 years, 94.2% of women who received Nerlynx were still alive with no cancer recurrence compared with 91.9% of women who did not receive Nerlynx.

Diarrhea was the most common side effect of the drug, but lessened with time. Other side effects included nausea and vomiting, abdominal pain, fatigue, rash, decreased appetite, muscle spasms, liver damage, dizziness, and joint pain.

Women who are pregnant or breastfeeding should not take Nerlynx because it may harm a developing fetus or newborn baby.

Nerlynx is marketed by Puma Biotechnology, Inc.

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