Pfizer, the new breast cancer drug, has filed a cdK 4/6 inhibitor new adaptive application in China

On December 7th the website of the Drug Review Center (CDE) of China's State Drug Administration announced that Pfizer had submitted two new drug listing applications for THE CDK 4/6 inhibitor palbociclib in China.
, according to an earlier Pfizer press release, the company is the world's first CDK 4/6 inhibitor.
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 and China in 2015 and 2018.
the public information, it is not yet certain that the declaration of the new adaptation to the listing.
Screenshot Source: CDE.com According to Pfizer's earlier press release, the world's first CDK 4/6 selective inhibitor, Pybersili, restores cell cycle control by inhibiting CDK 4/6, thereby blocking tumor cell proliferation.
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 listing in 2018 with the following adaptations: positive hormone-positive (HR-plus), human skin growth factor-inhibitor 2-negative (HER2-) local late stage or metastatic breast cancer in association with aromatic enzyme inhibitors, as the initial endocrine therapy for post-menopautic female patients.
globally registered studies have shown that the meso-progressed survival (PFS) in patients treated with HR-/HER2-breast cancer was 24.8 months.
submitted a new adaptive application in China, meaning the innovative treatment is expected to benefit more cancer patients.
, according to publicly available data, Pybersili has also been approved in the United States for endocrine therapy in female breast cancer patients, as well as advanced male breast cancer patients.
, in November 2017, the FDA approved a joint use with fluorovis groups to treat women with advanced or metastatic breast cancer who developed HR-/HER2-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.
has reached the main end of PFS, confirming that combination therapy can provide patients with another effective non-chemotherapy program to fight the disease.
addition, in April 2019, the FDA approved the use of aromatase inhibitors or fluoxetic groups to treat patients with breast cancer in men with HR-plus/HER2-advanced or metastases.
this approval is based on electronic medical records and data on the use of erbasilli in real-world male patients after the drug was introduced.
analysis found that pyrithroid showed similar safety in both male and female patients.
also means that for male breast cancer patients who lack treatment options, the drug is expected to benefit such patients.
cancer is the number one malignant tumor that seriously threatens women's health worldwide.
estimates that 90% of breast cancer is diagnosed at an early stage.
most common subsypes are HR plus/HER2-subsypes, accounting for 70% of the total number of breast cancer patients.
about 30 percent of patients diagnosed with HR-plus, HER2-early breast cancer still have a risk of cancer recurrence.
is 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%, there is an urgent need for innovative treatment options.
it is worth noting that for men, breast cancer may also occur.
because breast cancer patients are rare among men, make clinical trials against them difficult, slowing their access to innovative treatments to some extent.
approval of erbasily has opened up new treatment options for these patients.
addition to breast cancer, Pybersili is also exploring new adaptations in clinical studies.
, in combination with Roche's 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 trial to treat patients with the PIC3CA gene mutation with the PIC3CA gene has been launched in the first quarter of this year.
。