Which Attributes, in the Eyes of Oncologists and Payers, Will Allow Emerging Therapies to Gain Traction in a Market Experiencing Generic Erosion?
Drug development for advanced/metastatic, hormone-receptor (HR)-positive, human epidermal growth factor receptor-2 (HER2)-negative breast cancer has gained momentum in recent years. Following its approval in the United States and Europe in mid-2012 and approval in Japan in 2014, the mTOR inhibitor everolimus (Novartis’s Afinitor) in combination with exemestane (Pfizer’s Aromasin, generics) has rapidly become the sales-leading product for this therapy area. Furthermore, a first-in-class CDK4/6 inhibitor, Pfizer’s palbociclib (Ibrance) received FDA accelerated approval for first-line metastatic, HR-positive, HER2-negative breast cancer in combination with letrozole (Pfizer’s Femara, generics) in February 2015. The backbone of treatment in this population is hormonal therapies, most of which have suffered patent expiry; in addition, most patients in this population respond well to hormonal treatments, meaning improving efficacy with novel agents is difficult. Despite these challenges, the HR-positive, HER2-negative population holds the potential for significant commercial rewards for drug developers, given that it represents more than 70% of diagnosed incident cases of breast cancer.