Congratulations to Pfizer for receiving accelerated approval for its investigational new drug, IBRANCE to treat advanced breast cancer from the U.S. FDA on February 3. IBRANCE is an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6) involved in promoting the growth of cancer cells. IBRANCE is the first CDK4/6 inhibitor approved by the FDA to treat cancer.
Breast cancer in women is the second most common type of cancer in the US. According to the American Cancer Society, about 231,840 new cases of invasive breast cancer will be diagnosed in women and about 40,290 women will die from breast cancer in 2015 in the US. Worldwide, breast is one of the 5 most common sites diagnosed with cancer. IBRANCE is intended to treat postmenopausal women with estrogen receptor-positive and epidermal growth receptor 2-negative (ER+/HER2-) metastatic breast cancer. This group of patients represents the largest proportion of breast caner cases, and “This approval represents the first treatment advance for this group of women in more than 10 years,” said Mace Rothenberg, the head of oncology for Pfizer. IBRANCE was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.
“IBRANCE is the first CDK4/6 inhibitor approved by the FDA to treat cancer,” commented Qunsheng Ji, Vice President of Oncology at WuXi. “This represents a significant advance in bridging basic biology with patient benefit, and exemplifies the importance of understanding of the disease in developing innovative medicine for cancer treatment. The success of IBRANCE also represents the outcomes of collective and persistent efforts on scientific researches and drug discovery in cell cycle fried over the last two decades.”