Hengrui Pharmaceuticals "pyrroltinib" new indication listing application accepted

Hengrui Pharmaceuticals "pyrroltinib" new indication listing application accepted

InSeptember 15,The Drug Evaluation Center of the State Food and Drug Administration of China (CDE) the latest announcement, Hengrui Pharmaceuticals' maleate pyritinib tablets have submitted a new indication listing application, and has been accepted.

QueryCDE official website, since June, pyrrolitinib has only obtained CDE's record of accepting new indication listing applications on September 15. Combined with the information disclosed on the official website of Hengrui Pharmaceuticals, it is speculated that the new indication submitted by the drug may be: combined with trastuzumab plus docetaxel preoperative treatment of early or locally advanced HER2-positive breast cancer.

Pyrrotinib is a small molecule, irreversible, panErbB receptor tyrosine kinase inhibitors with targets including HER2, EGFR, and HER4. It can be with EGFR, HER2 and HER4 intracellular kinase ATP binding site covalent binding, prevent homo/heterodimer formation, irreversible inhibition of autophosphorylation, blocking the activation of downstream signaling pathways, inhibit tumor cell growth.

In August 2018, piretinib was conditionally approved in China for targeted therapy of human epidermal growth factor receptor 2(HER2) positive advanced breast cancer. In July 2020, the drug was fully approved by the NMPA and can be combined with capecitabine for the treatment of HER2-positive patients with recurrent or metastatic breast cancer who have not previously received or received trastuzumab.

The results of the study show that neoadjuvant therapy with docetaxel, trastuzumab and piretinib can completely relieve the overall pathology of patients (tpCR) rate increased significantly. Neoadjuvant therapy refers to systemic drug treatment before the main treatment of cancer. This type of therapy not only helps to shrink the tumor, kill invisible metastatic cancer cells as soon as possible, and reduce the risk of recurrence; it is also conducive to subsequent surgery, radiotherapy, etc. Treatment.

AccordingAccording to data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world's largest malignant tumor and one of the most common malignant tumors in women. Neoadjuvant therapy has long been used to shrink tumors, converting patients from inoperable to operable, while improving breast-conserving rates and reducing axillary staging.

It is worth mentioning that, just recently, a report was published in the Annals of Surgical Oncology (Annals of Surgical Oncology) shows that for patients with stage IV breast cancer with clear HER2 and hormone receptor status, the survival rate of patients undergoing neoadjuvant therapy is more significant than that of adjuvant therapy.

It is hoped that the new indications of Hengrui Pharmaceuticals Pyrrotinib will be approved as soon as possible, bringing benefits to more cancer patients.

InSeptember 15,The Drug Evaluation Center of the State Food and Drug Administration of China (CDE) the latest announcement, Hengrui Pharmaceuticals' maleate pyritinib tablets have submitted a new indication listing application, and has been accepted.

QueryCDE official website, since June, pyrrolitinib has only obtained CDE's record of accepting new indication listing applications on September 15. Combined with the information disclosed on the official website of Hengrui Pharmaceuticals, it is speculated that the new indication submitted by the drug may be: combined with trastuzumab plus docetaxel preoperative treatment of early or locally advanced HER2-positive breast cancer.

Pyrrotinib is a small molecule, irreversible, panErbB receptor tyrosine kinase inhibitors with targets including HER2, EGFR, and HER4. It can be with EGFR, HER2 and HER4 intracellular kinase ATP binding site covalent binding, prevent homo/heterodimer formation, irreversible inhibition of autophosphorylation, blocking the activation of downstream signaling pathways, inhibit tumor cell growth.

In August 2018, piretinib was conditionally approved in China for targeted therapy of human epidermal growth factor receptor 2(HER2) positive advanced breast cancer. In July 2020, the drug was fully approved by the NMPA and can be combined with capecitabine for the treatment of HER2-positive patients with recurrent or metastatic breast cancer who have not previously received or received trastuzumab.

The results of the study show that neoadjuvant therapy with docetaxel, trastuzumab and piretinib can completely relieve the overall pathology of patients (tpCR) rate increased significantly. Neoadjuvant therapy refers to systemic drug treatment before the main treatment of cancer. This type of therapy not only helps to shrink the tumor, kill invisible metastatic cancer cells as soon as possible, and reduce the risk of recurrence; it is also conducive to subsequent surgery, radiotherapy, etc. Treatment.

AccordingAccording to data released by the International Agency for Research on Cancer (IARC) of the World Health Organization in 2020, breast cancer has become the world's largest malignant tumor and one of the most common malignant tumors in women. Neoadjuvant therapy has long been used to shrink tumors, converting patients from inoperable to operable, while improving breast-conserving rates and reducing axillary staging.

It is worth mentioning that, just recently, a report was published in the Annals of Surgical Oncology (Annals of Surgical Oncology) shows that for patients with stage IV breast cancer with clear HER2 and hormone receptor status, the survival rate of patients undergoing neoadjuvant therapy is more significant than that of adjuvant therapy.

It is hoped that the new indications of Hengrui Pharmaceuticals Pyrrotinib will be approved as soon as possible, bringing benefits to more cancer patients.