All Articles

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).

Darolutamide, an investigational androgen receptor inhibitor, significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer (CRPC) compared with placebo in a large phase 3 clinical trial.

On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.

Options for the treatment of patients with advanced hormone receptor (HR)-positive, HER2-negative breast cancer are expanding.

The adjuvant use of the antibody-drug conjugate trastuzumab emtansine (T-DM1) led to a clinically meaningful and statistically significant improvement in invasive disease-free survival versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease, despite the use of neoadjuvant chemotherapy plus HER2-targeted therapy, according to the preliminary results from the phase 3 KATHERINE trial reported at the 2018 San Antonio Breast Cancer Symposium.

The large, randomized TAM-01 clinical trial demonstrated that 5-mg daily of tamoxifen for 3 years halved the risk for recurrence of breast intraepithelial neoplasia—atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), and lobular carcinoma in situ—in women after surgery and reduced the risk for new contralateral breast cancer by 75% compared with placebo.

Atezolizumab plus nab-paclitaxel was the first immunotherapy combination to improve disease-free survival (DFS) and overall survival (OS) in women with metastatic triple-negative breast cancer (TNBC) versus placebo plus nab-paclitaxel in the overall analysis of the IMpassion130 trial. Survival improvement was even more robust in the PD-L1–positive cohort.

Reaching pathologic complete response (pCR) after neoadjuvant chemotherapy correlates with significantly improved event-free survival (EFS) and overall survival (OS) in patients with localized breast cancer, according to a large comprehensive meta-analysis presented at the 2018 San Antonio Breast Cancer Symposium.

The discontinuation of a tyrosine kinase inhibitor (TKI) is considered safe and appropriate in consenting patients with chronic-phase chronic myeloid leukemia (CML) under specific circumstances and with careful molecular monitoring, according to the updated National Comprehensive Cancer Network (NCCN) management guideline for CML.

Germline testing should now be considered for any patient with pancreatic cancer, and molecular analysis of tumors should be considered in patients with metastatic disease, according to the most recent National Comprehensive Cancer Network (NCCN) guideline (version 1.2019) for the management of pancreatic cancer.