BREAST CANCER

Renowned scientist Ramon Parsons, MD, PhD, has been awarded an Outstanding Investigator Award (OIA) from the National Cancer Institute. The award guarantees $6.7 million for 7 years of research into the tumor-suppressing functions of the <em>PTEN</em> gene, which he discovered.

Laura J. van&rsquo;t Veer, PhD, discusses&nbsp;determining more accurate methods of treatment for patients with early- and late-stage breast cancer based on advances in genetic testing, specifically the 70-gene prognostic signature.

Lajos Pusztai, MD,&nbsp;discusses neoadjuvant and adjuvant treatment decisions for patients with HER2-positive breast cancer, as well as the potential of immunotherapy in the metastatic setting.<br /> &nbsp;

Adam M. Brufsky, MD, PhD, professor of Medicine, associate chief of Hematology/Oncology, co-director of the Comprehensive Breast Care Center, associate director of Clinical Investigation, University of Pittsburgh, discusses ovarian suppression and bone cancer management in breast cancer.

Richard S. Finn, MD, highlights the evolution of CDK 4/6 inhibition in the field of breast cancer and appropriate patient selection for this type of therapy.

Ribociclib (Kisqali) met its primary endpoint for progression-free survival (PFS) in premenopausal women with&nbsp;hormone-receptor (HR)&ndash;positive, HER2-negative (HR+/HER2-) advanced or metastatic breast cancer, according to topline results from the MONALEESA-7 trial, Novartis recently announced in a press release.

Richard S. Finn, MD, assistant professor of medicine, Department of Medicine, Division of Hematology/Oncology, Geffen School of Medicine, University of California, Los Angeles, discusses&nbsp;advances in the development of CDK4/6 inhibitors for the treatment of hormone receptor (HR)-positive breast cancer. &nbsp; &nbsp;

Fulvestrant (Faslodex) has been approved by the FDA for use in combination with the CDK4/6 inhibitor abemaciclib (Verzenio) as a treatment for patients with HR+/HER2- advanced or metastatic breast cancer who have progressed after endocrine therapy.

Amultihistology basket study proved the targetability of the <em>AKT1 E17K</em> mutation in human cancers by treating patients with various types of cancer harboring an <em>AKT1 E17K </em>mutation with AZD5363, an oral pan-AKT inhibitor, according to findings published in the <em>Journal of Clinical Oncology</em>.

Massimo Cristofanilli, MD, professor of medicine, Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, discusses overcoming resistance to endocrine therapy in ER+ breast cancer.

According to 10-year results from the TEAM study,

Mark E. Robson, MD, discusses the progress that has been seen in breast cancer care with the use of PARP inhibitors.

A supplemental New Drug Application for olaparib (Lynparza) has been granted a priority review by the FDA for the&nbsp;treatment of patients with germline <em>BRCA</em>-positive, HER2-negative metastatic breast cancer who have previously received chemotherapy in the neoadjuvant, adjuvant, or metastatic settings,&nbsp;AstraZeneca and Merck, the co-developers of the PARP inhibitor, recently announced.

Ruth O&rsquo;Regan, MD, division head of Hematology and Oncology in the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, discusses treating premenopausal women with breast cancer.

Based on data from the phase III MONARCH 3 trial, a new drug application for abemaciclib (Verzenio) has been granted a priority review by the FDA for&nbsp;use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

Frankie Ann Holmes, MD, Texas Oncology, discusses challenges with neoadjuvant endocrine therapy in breast cancer.

Neoadjuvant Therapy for HER2+ Early Breast Cancer

A look back at all the FDA news that occurred in the month of September.

A supplemental biologics license application for pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer&nbsp;has been granted a priority review by the FDA.&nbsp;

Abemaciclib (Verzenio) has been approved by the FDA for use as a monotherapy and in a combination regimen for patients with HR-positive/HER2-negative breast cancer. As a monotherapy, the CDK4/6 inhibitor has been approved for patients with&nbsp;metastatic disease who have previously received endocrine therapy and chemotherapy, and as a combination, abemaciclib has been approved for use with fulvestrant for women with advanced&nbsp;breast cancer with disease progression following endocrine therapy.