Pfizer filed a 4/6 inhibitor new adaptor listing application in China

December 7th, Pfizer filed an application in China for the listing of two new drugs, the CDK 4/6 inhibitor palbociclib, on the website of the Drug Review Center (CDE) of the State Drug Administration of China. According to an earlier Pfizer press release, Pfizer is the world's first CDK 4/6 inhibitor. It has been recognized by the FDA as a breakthrough therapy and has been approved for use in the treatment of advanced breast cancer in the United States in 2015 and 2018. According to public information, it is not yet possible to determine the new adaptation to the declaration.According to Pfizer's earlier press release, the world's first CDK 4/6 selective inhibitor, Pypenicelli, restores cell cycle control by inhibiting CDK 4/6, thereby blocking tumor cell proliferation. The company's 2019 results show that the drug's clinical needs are evident in its $4,961 million sales in 2019, one of the main drivers of Pfizer's earnings growth.In China, the company was approved for market in 2018 with the following adaptations: treatment of hormone-positive (HR-plus), human skin growth factor subject 2 negative (HER2-) local late stage or metastatic breast cancer, as an initial endocrine treatment for post-menopautic female patients. The Global Registered Study showed that the mid-progressed survival (PFS) in patients with HR-/HER2-breast cancer was 24.8 months.The filing of a new adaptation listing in China means the innovative treatment is expected to benefit more cancer patients. According to publicly available information, erbasily is also approved in the United States for endocrine therapy in female breast cancer patients, as well as advanced male breast cancer patients.Among them, in November 2017, Pircilli was approved by the FDA to be used in a joint use with fluorovis groups to treat women with advanced or metastatic breast cancer who developed the disease after endocrine therapy. In a Phase 3 clinical trial called MONK 2, patients who received 500 mg of fluoxetic group and 150 mg of pyrithroid were significantly longer than those who received fluoxetic group and placebo, and the researchers assessed a significant 7.1-month (16.4-month vs. 9.3-month) increase in the medium PFS. The study reached the main endpoint of PFS and confirmed that combination therapy could provide patients with another effective non-chemotherapy solution to fight the disease.In addition, in April 2019, Pybersili was approved by the FDA to be used in association with aromatase inhibitors or fluorovis groups to treat patients with breast cancer in men with HR-plus/HER2-advanced or metastasis. The approval is based on electronic medical records and data on the use of pyrethroids in real-world patients after the drug was introduced. The analysis found that erbasilli showed similar safety in both male and female patients. It also means that for male breast cancer patients who lack treatment options, the drug is expected to benefit such patients.Breast cancer is the number one malignant tumor that seriously threatens women's health in the world. It is estimated that 90% of breast cancer is diagnosed at an early stage. The most common subsype is HR plus/HER2-subsype, accounting for 70% of the total number of breast cancer patients. About 30% of patients diagnosed with HR-plus, HER2-early breast cancer still have a risk of cancer recurrence. Different from the diversification of treatment methods for early breast cancer, the overall medium survival of patients with advanced breast cancer is only 2-3 years, the five-year survival rate is only about 20%, and innovative treatment is urgently needed.It is worth mentioning that for men, breast cancer may also occur. But because breast cancer patients are rare among men, clinical trials against them are difficult, delaying their access to innovative treatments to some extent. The approval of Pybersili has opened up new treatment options for these patients.In addition to breast cancer, Pybersili is also exploring new adaptations in clinical studies. In combination with Roche PI3K alpha inhibitors and estrogen therapy, it has shown encouraging results in phase 1/1b clinical trials in patients treating solid tumors with PIC3CA mutations. Phase 3 clinical trials of this combination therapy for patients with HR-/HER2-metastasis breast cancer with the PIK3CA gene mutation were launched in the first quarter of this year. (Pharmaceutical Mingkang
):. .. Retrieved Apr5, 2019, from[3] Faslodex receives US FDA approval for the treatment of advanced breast cancer in combination with abemaciclib. Retrieved Nov 16, 2017, from AstraZeneta's website