Breast Cancer

On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.

On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.

On October 16, 2018, the FDA approved talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with HER2-­negative, locally advanced or metastatic breast cancer and deleterious or suspected deleterious germline BRCA mutation, as identified by an FDA-approved test.

“We are confident that this will mark the first steps toward a reduction of the duration of trastuzumab in many women with HER2-positive breast cancer,” says Helena M. Earl, MBBS, PhD, FRCP.

Breast cancer affects more women than any other type of cancer, and represents 15% of all new cancer cases in the United States. A total of 252,710 new breast cancer cases were estimated to be diagnosed in 2017, and more than 40,600 deaths. The prognosis worsens for patients with locally advanced breast cancer and even more so for those with metastatic disease.

Breast cancer is one of the most common cancer diagnoses in the United States. The National Cancer Institute estimates that 252,710 American women will be diagnosed with breast cancer and 40,610 will die from the disease in 2017. For the majority (62%) of women with breast cancer, the disease is confined to the breast, and the 5-year survival approaches 100%. However, for women with metastatic disease, the likelihood of survival at 5 years drops to 27%.