FDA unexpectedly approved Nerlynx therapy to reduce the risk of breast cancer recurrence

Food and Drug Administration (FDA), US has just officially approved the use of Nerlynx therapy to treat early-stage HER2-positive breast cancer to reduce the risk of recurrence.

Previously, breast cancer was the most common form of cancer in the United States, but according to the National Cancer Institute (NCI), an estimated 252,710 women were diagnosed with breast cancer by 2017 and 40,610 would die of cancer. breast letter.

About 15% of breast cancer patients with tumors are HER2-positive.

Dr. Richard Pazdur, Director of the Center for Oncology of the FDA and Director of the Office, said: "HER2-positive breast cancer is malignant tumors and can spread to other parts of the body, It is important to use a variety of supportive therapies as well as timely treatment plans.Now, these patients have another option after initial treatment that may help prevent cancer. come back " .

Nerlynx, or neratinib, is the first extended adjuvant therapy, a type of therapy that is performed after initial treatment to reduce the risk of recurrence, for HER2-positive breast cancer. It works by blocking certain enzymes that promote the growth of cancer cells.

FDA has approved the use of Nerlynx for adult patients who have been treated with trastuzumab.

Scientists studied the safety and efficacy of Nerlynx in a clinical trial with 2,840 patients with early-stage HER2 breast cancer treated with trastuzumab about two years ago.

The study showed that after two years, 94.2% of Nerlynx patients did not have breast cancer recurrence or death compared to 91.9% in patients who only took placebo.