Is Palbociclib on the market?

Palbociclib (Palbociclib) was developed by Pfizer after discovering that cyclin-dependent kinases are key regulators of cell growth. Originally approved by the U.S. Food and Drug Administration (FDA) in 2015 for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer, its indication was updated in April 2019 to include male patients and demonstrate safety and clinical efficacy based on findings from postmarketing reports and electronic health records.

In 2016, the European Medicines Agency (EMA) decided that the benefits of palbociclib outweighed its risks and that it had been shown to extend patients' survival by an average of six to 10 months without their disease worsening, which was considered to have clear clinical value. Regarding safety, the main risk is neutropenia, a well-known risk of many cancer drugs that is considered manageable.

The original drug of palbociclib has been launched in China and has entered the scope of Class B medical insurance, but reimbursement is limited to patients who meet the indications. The price of each box may be more than more than 4,000 yuan. The price of palbociclib's original drug, 125mg*21 tablets per box, sold overseas may be around RMB 10,000 (the price may fluctuate due to exchange rates). There are also generic palbociclib drugs produced in other countries. The price of 125mg*21 tablets produced by Bangladesh pharmaceutical factory may be around 900 yuan per box (the price may fluctuate due to the exchange rate), which is cheaper. The pharmaceutical ingredients of generic drugs are basically the same as those of domestic and foreign original drugs.