Breast cancer patients in advanced stage now find hope as the Saudi FDA approved palbociclib in combination with letrozole for the treatment of postmenopausal women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic (advanced) breast cancer (mBC) as initial endocrine-based therapy for their disease.1 Last year, palbociclib received an accelerated approval from the US Food and Drug Administration (FDA) and was the first cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor approved by the governing body. Professor Samia Al-Amoudi, CEO, Sheikh Mohammed Hussein Al-Amoudi Center of Excellence in Breast Cancer, said: "Breast cancer is the most common cause of cancer death in women in the Middle East and North Africa and is responsible for 21% of female cancer deaths".2 In Saudi Arabia breast cancer is the most common cancer among female and constitute 29.1% of all women's cancer according to cancer registry in 2013. The coming burden of cancer is estimated to show increase in incidence and mortality by 350% and 160% respectively by 2050, according to a study by Ezzeldin M. Ibrahim, Chief Medical Officer and Chairman of Research Center in International Medical Center Hospital in Jeddah. This is alarming and shows that proper steps need to be taken by all involved in early detection, prevention and management. Palbociclib inhibits the enzymes called cyclin-dependent kinases (CDKs) 4 and 6, which promote the growth of cancer cells. It is indicated for postmenopausal women with ER+/HER2- metastatic breast cancer who have not yet received and endocrine-based therapy. It is to be used in combination with letrozole, a product used to treat certain kinds of breast cancer in postmenopausal women.1 In the US, a clinical study was held wherein palbociclib was tested in 165 postmenopausal women with ER+/HER2- with locally advanced or metastatic breast cancer who did not have previous systemic treatment for the advanced disease. The study participants were randomly assigned to receive palbociclib combined with letrozole alone. The results showed that participants who received palbociclib and letrozole lived about 20.2 months without mBC progressing (known as progression-free survival or PFS), a substantial improvement as against the 10.2 months of PFS observed in women who were only on letrozole.3 The recommended dose of palbociclib is 125 mg taken orally once for 21 days followed by 7 days of treatment in 28-day cycles. Palbociclib should be taken with food and in combination with letrozole 2.5 mg once daily continuously.1 Patients are encouraged to take their doses at approximately the same time each day and not to combine with other medications apart from letrozole. PIH LEAD Alaa Gamal said: "Our strength in research and innovation has just translated novel science into meaningful medicine. There is hope as efforts to develop newer and more effective treatments continue to help patients have a quality of life. Thanks to our strong partnerships with researchers, we now have a first-line treatment option which has shown its benefits in combination with letrozole to help achieve a longer progression-free survival for postmenopausal women with ER+/HER2- metastatic breast cancer." — SG
