BREAST CANCER

Erika P. Hamilton, MD, discusses the data leading up to the Next MONARCH 1 study of abemaciclib plus tamoxifen or abemaciclib alone with metastatic breast cancer.

Here is a look back at the FDA happenings from the month of April 2021.

The experts describe the SOPHIA study of margetuximab in HER2+ advanced breast cancer.

Experts have a detailed conversation on the NALA trial of neratinib and capecitabine for HER2+ metastatic breast cancer.

Presentation and considerations for relapsed HER2+ metastatic breast cancer with progressing brain metastases.

The FDA's Oncologic Drugs Advisory Committee voted 7 to 2 in favor of the continued approval of atezolizumab in combination with nab-paclitaxel for the treatment of patients with advanced or metastatic triple-negative breast cancer whose tumors are positive for PD-L1 expression.

As long-awaited results from pivotal trials are revealed during major medical conferences, community oncologists in the clinic look forward to the resulting approvals with much anticipation.

For patients with metastatic breast cancer, research suggests that utilizing a multi-omics approach to personalized therapy that incorporates information about actionable oncogenic drivers with critical biological data may be feasible and better than DNA sequencing alone.

Gedatolisib, a first-in-class PI3K/mTOR inhibitor, plus palbociclib and endocrine therapy demonstrated tolerability and preliminary efficacy in patients with ER+/HER2- advanced or metastatic breast cancer.

The FDA granted a regular approval to sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

Gerardo Umanzor, MD, explains the potential benefits of oral paclitaxel and encequidar compared with the intravenous formulation for the treatment of metastatic breast cancer during the coronavirus disease 2019 pandemic.

The FDA has administered a Breakthrough Device Designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer.

The FDA has issued a complete response letter to Merck’s supplemental Biologics License Application which sought FDA approval of pembrolizumab as treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment.

A panel of experts review the tucatinib regimen including adverse effects to keep an eye on.

Key opinion leaders consider later-lines of therapy in metastatic breast cancer with lung and brain involvement.

The experts discuss data from clinical trials of metastatic breast cancer with brain involvement.

The experts present and discuss a case of a patient with relapsed HER2+ metastatic breast cancer with stable brain metastases.

The panelists discuss clinical experience with the HER2CLIMB regimen, including main adverse effects.

The experts have a detailed conversation on the HER2CLIMB trial, including third-line treatment options and the importance of having a detailed and balanced conversation with patients.

Experts discuss the treatment considerations for HER2+ metastatic breast cancer and provide an overview of the DESTINY-Breast01 trial.

The experts discuss a case presentation of a 63-year-old woman with relapsed HER2+ metastatic breast cancer and discuss rate of relapse in this patient population.

Experts in breast cancer review clinical cases, discuss individualized treatment options and key clinical trials.

The FDA has granted 2 breakthrough device designations to the molecular residual disease test, Signatera.

As the understanding of genetic risk factors in breast cancer continues to grow, professional organizations have sought to provide specific recommendations for genetic testing that would prevent overtesting yet still diagnose as many mutations as possible in patients.

Clinical development of the oral chemotherapy agent, tesetaxel is being discontinued as the treatment of metastatic breast cancer, colorectal cancer, and other solid tumors after the FDA provided feedback on a pre-New Drug Application.