BREAST CANCER

Debu Tripathy, MD, discusses the use of CDK4/6 inhibitors for the treatment of HER2-negative breast cancer based on the results from the phase III MONALEESA-7 trial.

Neelima Denduluri, MD, discusses each CDK4/6 inhibitor as potential first-line and second-line therapies based on the data from the PALOMA-2, MONALEESA-2 and -7, and MONARCH 3 trials, which led to their approvals.

Massimo Cristofanilli, MD, discusses the clinical utility of liquid biopsies—specifically focusing on CTCs and cfDNA—and highlights ongoing research in the space.

Jame Abraham, MD, discusses the key takeaways from the phase Ib study of trastuzumab emtansine in combination with neratinib in patients with HER2-positive breast cancer.

Patients with heavily pretreated metastatic HER2-positive breast cancer saw an improvement in progression-free survival with margetuximab combined with chemotherapy compared with trastuzumab and chemotherapy, according to findings from the phase III SOPHIA trial.

A supplemental Biologics License Application for ado-trastuzumab emtansine (T-DM1; Kadcyla) has been submitted to the FDA seeking approval for the agent as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.

Stacy L. Moulder, MD, discusses the challenges in drug development for triple-negative breast cancer, specifically in the neoadjuvant setting.

A look back at all the FDA news in oncology from the month of January 2019, including several new approvals, breakthrough therapy designations, and a partial clinical hold.

Debu Tripathy, MD, discusses the subgroup analysis from the MONALEESA-7 trial, as well as data from a pooled analysis looking at ribociclib in several clinical trials.

In findings from the phase II next MONARCH 1 trial, single-agent abemaciclib continued to be safe and effective for patients with hormone receptor–positive, HER2-negative advanced breast cancer who have progressed on or following endocrine therapy.

General Cancer

SB3, a trastuzumab biosimilar, has been granted FDA approval for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.