When was Neratinib launched?

Neratinib (Neratinib) was approved by the U.S. Food and Drug Administration (FDA) in July 2017 for the extended adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The trade name of Puma Biotechnology is Nerlynx. In February 2020, the FDA approved neratinib in combination with capecitabine for adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more anti-HER2-based treatment regimens in the metastatic setting.

In August 2018, the European Medicines Agency (EMA) concluded that neratinib has been shown to be beneficial in women with HER2-positive early-stage breast cancer, and that this benefit appears to be mainly beneficial to women with hormone receptor-positive disease. Although side effects, particularly diarrhea, can be severe and lead to discontinuation of treatment, post-operative treatment with neratinib and trastuzumab, also marketed under the trade name Nerlynx, would be a reasonable option for patients with HER2-positive, hormone receptor-positive early-stage breast cancer.

In 2020, the original drug of neratinib was launched in China under the name of neratinib maleate tablets, and subsequently entered the scope of medical insurance, but reimbursement is limited to patients who meet the indications. The price of each box of 40mg*180 tablets may be around RMB 7,000. Generic drugs of neratinib are also sold overseas. The drug ingredients are basically the same as those of the original drug. The price of 40mg*180 tablets produced by Bangladesh pharmaceutical factory may be around 4,000 yuan per box (the price may fluctuate due to the exchange rate). For more information about overseas drugs and specific prices, please consult Yaode Medical Consultant.