Hengrui Medicine's application for the treatment of HER2-positive breast cancer with pyrrotinib has been accepted

September 16, 2021

According to the data of Yaozhi, Hengrui Medicine's application for the new indications of pyrrotinib maleate tablets was accepted by CDE. According to a press release issued by Hengrui Medicine, the new indication submitted by pirotinib may be: combined with trastuzumab plus docetaxel, preoperative treatment of early or locally advanced HER2-positive breast cancer.

Data source: Yaozhi data

Pirrotinib is a small molecule, irreversible, pan-ErbB receptor tyrosine kinase inhibitor. It was conditionally approved for marketing in August 2018, and was fully approved by the National Medical Products Administration in July 2020. It can be combined with capecitabine and is suitable for the treatment of HER2-positive, no previous or trastuzumab relapse Or patients with metastatic breast cancer. In June of this year, Hengrui Medicine announced that in a phase 3 clinical study named HR-BLTN-III-NeoBC, the main research endpoint of pyrrotinib maleate tablets reached the pre-specified superiority standard. Hengrui Medicine Said that it plans to submit a pre-listing communication application to CDE in the near future. In the HR-BLTN-III-NeoBC study, a total of 355 patients with early or locally advanced HER2-positive breast cancer were enrolled. They were randomized 1:1 and received pyrrotinib combined with trastuzumab plus docetaxel, or placebo combined with trastuzumab plus docetaxel. The results of the study showed that neoadjuvant therapy combined with docetaxel, trastuzumab and pirotinib can significantly increase the overall pathological complete remission (tpCR) rate of patients. Neoadjuvant therapy refers to the systemic drug treatment performed before the main cancer treatment. This type of therapy not only helps to shrink the tumor, kill invisible metastatic cancer cells early, and reduce the risk of recurrence; it is also beneficial to follow-up surgery, radiotherapy, etc. treatment.

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