Why does neratinib/neratinib (He Li'an) need to be taken for one year?

Neratinib/neratinib (Neratinib) is an adjuvant treatment drug for HER2-positive breast cancer and is mainly used for extended adjuvant treatment of patients with early-stage breast cancer. Its taking cycle is one year, which is mainly based on its therapeutic mechanism and clinical research results.

The mechanism of action of neratinib is to prevent the proliferation and spread of cancer cells by inhibiting the activation ofHER2 receptor. In patients with HER2-positive breast cancer, the HER2 receptor is often overexpressed, causing tumor cells to grow abnormally. Neratinib reduces the risk of breast cancer recurrence by long-term inhibiting the HER2 receptor signaling pathway. According to clinical data, neratinib can significantly reduce the recurrence rate of breast cancer, especially in patients with early-stage breast cancer. Therefore, treatment regimens with neratinib are usually recommended to last for one year to maximize the effectiveness of the treatment and prevent the cancer from coming back.

The treatment strategy for patients with early breast cancer is usually based on postoperative adjuvant therapy, in which intensive adjuvant therapy is the key to improving patient survival rate. Clinical studies have shown that the use of neratinib as intensive adjuvant therapy can reduce the recurrence of HER2-positive breast cancer to a certain extent, especially in patients treated with trastuzumab (Herceptin). Therefore, patients need to continue taking neratinib for one year according to the prescribed treatment cycle to ensure the maximum effect of the treatment.

In addition, the dose and treatment time of neratinib are usually adjusted according to the patient's specific conditions under the guidance of a doctor. Therefore, neratinib needs to be taken for one year, mainly because it can effectively reduce the risk of breast cancer recurrence and maximize its efficacy in long-term treatment. For HER2-positive breast cancer patients, especially those with early-stage breast cancer, continued use of neratinib can help consolidate the treatment effect, improve survival rate, and significantly reduce the chance of disease recurrence.

Reference materials:https://www.ema.europa.eu/en/documents/product-information/nerlynx-epar-product-information_en.pdf