BREAST CANCER

It’s been a busy month at the FDA. Here’s a look back at all the news in the oncology field to come out of the FDA during the month of May.

Joyce A. O’Shaughnessy, MD, chair of Breast Cancer Research and the Celebrating Women Chair in Breast Cancer at Baylor-Sammons Cancer Center, discusses the promise seen with abemaciclib for the treatment of breast cancer.

Hope S. Rugo, MD, discusses the differentiating factors of abemaciclib among the CDK 4/6 inhibitors for breast cancer treatment.

Anees B. Chagpar, MD, associate professor of Surgery (Oncology), director of The Breast Center at Smilow Cancer Hospital at Yale-New Haven, Yale Cancer Center, discusses ongoing clinical trials in the field of triple-negative breast cancer (TNBC).

Neratinib has been recommended for approval by the FDA’s Oncologic Drugs Advisory Committee in a 12-4 vote for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab.

An overview of updated guidelines for the management of invasive breast cancer, issued by the National Comprehensive Cancer Network.

More Stage I cancers were diagnosed after the passage of the Affordable Care Act within 5 screenable disease types (colorectal cancer, female breast cancer, cervical cancer, lung cancer, and prostate cancer) than were diagnosed before ACA implementation.

Ruth O’Regan, MD, discusses results of BELLE-3, a phase III study of buparlisib (BKM120) plus fulvestrant (Faslodex) in postmenopausal women with hormone receptor (HR)-positive, HER2-negative breast cancer.

Denise Yardley, MD, senior investigator at the Sarah Cannon Research Institute, discusses the role of nab-paclitaxel (Abraxane) in the treatment of triple-negative breast cancer (TNBC). 

The FDA has given its approval to co-packaging of the oral medications ribociclib (Kisqali) and letrozole (Femara) for the treatment of postmenopausal women with HR-positive, HER2-negative advanced breast cancer.

Wolfgang Janni, MD, PhD, discusses toxicity management with neratinib and other agents for HER2-positive breast cancer, as well as emerging treatments and impactful trials in the field.

Debu Tripathy, MD, discusses current and emerging treatment strategies in the neoadjuvant setting for patients with HER2-postive breast cancer.

NYU Langone’s Perlmutter Cancer Center has announced that Ophira Ginsburg, MD, will be director of its new High-Risk Program, which will identify, study, and care for patients with hereditary syndromes that increase their risk for developing cancer.

Elizabeth A. Mittendorf, MD, PhD, associate professor, department of surgical oncology, University of Texas MD Anderson Cancer Center, discusses the promise immunotherapy has shown thus far in breast cancer, particularly triple-negative breast cancer (TNBC). 

An overview of FDA news that happened in April.

The treatment paradigm for HER2-positive breast cancer continues to focus on minimizing the role of chemotherapy and determining the optimal combination of HER2-targeted agents for specific patient subsets.

The addition of abemaciclib to letrozole or anastrozole improved progression-free survival over either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study.

Veliparib fell short of meeting the primary endpoint in a phase III non–small cell lung cancer trial and a triple-negative breast cancer trial.

An Oncologic Drugs Advisory Committee hearing has been scheduled by the FDA for May 24, 2017, to discuss a new drug application for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab.

Steven J. Katz, MD, discusses a population-based survey which examined the association between patient report of surgical recommendation against contralateral prophylactic mastectomy and to what extent it was discussed with the surgeon.

The American Association for Cancer Research has announced Michael A. Caligiuri, MD, will serve as its president and Elizabeth M. Jaffee, MD, will serve as its president-elect for the 2017-2018 term.

Debu Tripathy, MD, chair of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, discusses neoadjuvant treatment strategies in HER2-positive breast cancer.

Hope S. Rugo, MD, discusses the final overall analysis of the phase II MONARCH 1 trial, which explored the use of abemaciclib for the treatment of patients with pretreated hormone-receptor (HR)-positive/HER 2-negative advanced breast cancer.

Giuseppe Curigliano, MD, PhD, discusses recent trials of immunotherapy and chemotherapy in triple-negative breast cancer, as well as the future role of immunotherapy in the treatment of breast cancer.

 According to the results of a phase I study of single agent anti-PD-L1 atezolizumab (Tecentriq) in metastatic triple-negative breast cancer (mTNBC), ten percent of patients showed impressive long-term survival, although researchers said that aside from some biomarker evidence, it’s yet unclear why the drug was more effective in this subset of patients.