BREAST CANCER

The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

As the new coronavirus disease 2019 creates problems internationally, health-wise and economically, it is also becoming a cause for concern throughout the oncology community.

Despite evidence from previous studies that showed that platinum-based chemotherapy agents are active in patients with breast cancer, platinum-based chemotherapy was not found to be superior to standard chemotherapy in terms of eliciting pathologic complete responses in patients with HER2-negative breast cancer carrying a BRCA mutation, according to data from the INFORM trial published in the Journal of Clinical Oncology.

The combination of fulvestrant and capivasertib prolonged progression-free survival compared with placebo in patients with estrogen receptor-positive breast cancer who were previously treated with aromatase inhibition, according to results from the phase II FAKTION trial, published in The Lancet Oncology.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

Elizabeth A. Mittendorf, MD, PhD, discusses different data looking at sequencing therapies and why it is important in the breast cancer setting.<br /> &nbsp;

The FDA has approved a supplemental New Drug Application for neratinib in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have previously received 2 or more anti&ndash;HER2-based regimens in the metastatic setting, according to a press release issued by the manufacturer Puma Biotechnology, Inc.

A fixed-dose subcutaneous formulation of pertuzumab and trastuzumab in combination with intravenous chemotherapy has been accepted by the FDA for the treatment of eligible patients with HER2-positive breast cancer, which is supported by results of the phase III FeDeriCa study.

To help clinicians cope with an increasing number of geriatric patients with cancer, the Association of Community Cancer Centers is addressing this problem with a 2-pronged approach that focuses on the delivery of care and diagnostic assessment.

The FDA has granted Priority Review to the New Drug Application for the combination of tucatinib, trastuzumab, and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The prescription Drug User Fee Act, the FDA has set a target action date of August 20, 2020.&nbsp;

First-line treatment with pembrolizumab in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients with metastatic triple-negative breast cancer who had PD-L1 expression in their tumors, meeting one of the coprimary end points of the phase III KEYNOTE-355 trial, according to the results of an interim analysis reported in a press release from Merck.

Jason Williams, MD, the director of Interventional Oncology and Immunotherapy oncologist at the Williams Cancer Institute, discusses a study in which an immunotherapy combination was administered intratumorally to patients with liver metastases linked to breast cancer, which he presented in a poster at the 2019 Society of Immunotherapy of Cancer Annual Meeting.

Patients with metastatic breast cancer who carry rare mutations identified by circulating tumor DNA responded to matched targeted therapies, according to results of the plasma-MATCH trial presented during the 2019 San Antonio Breast Cancer Symposium.

Patients with metastatic breast cancer who carry rare mutations identified by circulat&shy;ing tumor DNA responded to matched targeted therapies, according to results of the plasmaMATCH trial presented during the 2019 San Antonio Breast Cancer Symposium.&nbsp;Specifically, patients with HER2 mutations responded to neratinib and patients with AKT1 mutations responded to capivasertib.

Rashmi K. Murthy, MD, discusses the pivotal HER2CLIMB trial, which evaluated the addition of tucatinib to trastuzumab plus capecitabine in patients with HER2-positive metastatic breast cancer.

Jasmeet C. Singh, MD, discusses the future of the treatment landscape for HER2-positive breast cancer following positive new research presented at the 2019 San Antonio Breast Cancer Symposium.

The CDK4/6 inhibitor ribociclib plus endocrine therapy with letrozole may induce molecular downstaging of disease in certain patients with high-risk, early-stage, hormone receptor&ndash;positive, HER2-negative breast cancer compared with multiagent chemotherapy, according to results from the randomized phase II CORALLEEN trial.

In an interview with&nbsp;Targeted Oncology, Elizabeth Mittendorf, MD, PhD, discussed the highlights from the 2019 San Antonio Breast Cancer Symposium for the treatment of patients with triple-negative breast cancer, as well as those with&nbsp;HER2-positive breast cancer. She also shared her thoughts on the key takeaways from the 2019 meeting.

Neoadjuvant systemic therapy may enable patients with triple-negative breast cancer who are ineligible for breast conservation therapy to become eligible, according to a prespecified secondary analysis of the results from the phase III BrighTNess trial.

Although groundbreaking research findings are met with much fanfare during large medical conferences, their practical application to the community oncology clinic may not always be immediately clear.

Integrating a geriatric assessment into the care of older adults who are receiving cancer treatment in communi&shy;ty oncology practices improves patient and caregiver satisfaction and encourages commu&shy;nication about aging-related concerns, accord&shy;ing to results of a clinical trial that enrolled 541 patients with advanced cancer.

The present and future benefits of telehealth in oncology can be observed through Tahoe For&shy;est Cancer Center and its affiliation with the UC Davis Cancer Center, use of other remote clinics, and participation in virtual tumor boards. Even though there are roadblocks to telehealth reaching more locations and more patients, the potential benefit warrants the time needed to get over those hurdles.

The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31^st&nbsp;for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances,&nbsp;Targeted Oncology&nbsp;followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

David Rimm, MD, PhD, discusses the key takeaways from the results of a phase I/II trial presented in a poster at the 2019 San Antonio Breast Cancer Symposium, which evaluated neoadjuvant checkpoint inhibition in a small subset of patients with triple-negative breast cancer.<br /> &nbsp;