China approves Breakthrough Therapy Drug for Breast Cancer


On July 31st, the China National Drug Administration (CNDA) has approved the use of IBRANCE (palbociclib), a cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor designed for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.

Cancer is slowly becoming the leading cause of death at a global level, and unfortunately, China is one of the countries that has the worst statistics.  Among the approximately 270.000 new breast cancer cases discovered each year, the mortality rate is close to 25%. Because of lack of awareness and limited testing facilities, about one-tenth of patients are diagnosed in the latter stages, meaning fewer treatment options are available. Early breast cancer patients that undergo therapy still have between thirty and forty percent chance of recurrence and possibly developing advanced breast cancer.

The introduction of IBRANCE is hoped to be just the first step in a series of new personalized treatments. Palbociclib is an oral inhibitor that targets the CDKs 4 and 6 regulators, known cancer indicators, disrupting the proliferation of tumor cells.

Tests that involved IBRANCE in combination with letrozole, conducted on patients with HR+/HER2-, resulted in median PFS of 24.8 months, a considerable improvement from what standard courses offered, just 14.5 months. The drug was already successfully deployed in 86 countries, including the U.S. and most of E.U.

Pfizer, a leading pharmaceutical company and manufacturer of IBRANCE, is working closely with the Chinese government as part of the ‘Healthy China 2030‘ initiative. Even though it is the second largest economy in the world, China still struggles with many health issues, mostly because of overpopulation and uneven resource distribution. This was an important measure that will hopefully improve the health care for the millions of people that desperately need it.