HER2-Positive Breast Cancer

In addition to being approved to detect the HER2 biomarker in breast cancer, the assay was approved as a companion diagnostic for trastuzumab therapy.

Black Diamond Therapeutics announced that the FDA granted fast track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 Exon 20 insertion mutation.

The FDA approved phesgo for injection under the skin to treat adult patients with early and metastatic HER2-positive breast cancer.

The FDA has cleared an investigational new drug application for BPX-603, a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2.

Tucatinib in combination with trastuzumab and capecitabine yielded significant intracranial responses in patients with previously treated HER2-positive metastatic breast cancer and brain metastases.

A recent study found 32 new sites on the human genome where variations in a woman’s DNA could alter her risk level, both increase and decrease, of getting breast cancer.

The multi-center trial is comprised of 2 phases, with phase I determining the maximum tolerated dose of palbociclib and phase II determining the clinical benefit rate of treatment with anastrozole, palbociclib, trastuzumab, and pertuzumab.

As prospective clinical trials continue to accrue data, the researchers indicated that this data may help clinicians in decision-making regarding adjuvant systemic therapy for patients with small HR-positive, ERBB2-positive breast cancers.

This study observed a positive association between Indigenous American genetic ancestry and HER2-positive breast cancer, suggesting that the high incidence of HER2-positive subtypes in Latinas may be due to population and subtype-specific genetic risk variants.

The FDA approved tucatinib in combination with chemotherapy for the treatment of adult patients with advanced forms of HER2-positive breast cancer.

Immutep reported positive data from the randomized phase IIb AIPAC clinical trial of eftilagimod alpha and paclitaxel in HER2-negative, HR-positive metastatic breast cancer (MBC).

The FDA 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 received at least 2 prior anti-HER2-based regimens in the metastatic setting.

The FDA accepted a biologics license application for the fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with IV chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.

The breast cancer expert, in an interview with CancerNetwork®, discussed advances in the field of breast cancer and what we can expect to see in the pipeline moving forward.

The FDA granted a priority review to a new drug application submitted by Seattle Genetics, Inc. for tucatinib to treat patients with HER2-positive breast cancer.

An analysis of the results of the phase III PANTHER trial showed that a combination of tailored dose-dense adjuvant chemotherapy and trastuzumab decreased the relative risk of relapse for patients with HER2-positive breast cancer.

The breast cancer expert spoke about the results presented in the trial, noting the benefit seen with longer follow-up.

The nurse practitioner from UCLA Health spoke about the expanding treatment options in this setting.

The FDA granted accelerated approval to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

Seattle Genetics announced the development after data was presented at the 2019 San Antonio Breast Cancer Symposium.

The breast cancer expert discussed 2 advances in HER2-positive breast cancer treatment that healthcare providers should look for.

T-DXd demonstrated improved and durable response rates in heavily pretreated patients with advanced HER2-positive breast cancer.

The addition of pertuzumab to the previous standard of trastuzumab plus chemotherapy as an adjuvant therapy for patients with operable HER2-positive early breast cancer continued to reduce the risk for recurrence and death during a 6-year updated analysis.

Adjuvant therapy with S-1, an oral fluoropyrimidine-based drug, plus endocrine therapy postoperatively significantly increased invasive disease-free survival (IDFS) in patients with HR-positive, HER2-negative breast cancer.

The Food and Drug Administration approved the first generic for everolimus, which can provide a safe, effective, lower cost alternative to the brand-name drug it references.

Henlius announced that their multicenter phase III study met its primary end point of best overall response rate at week 24.

Oncotype DX® Breast Recurrence Scores from the National Cancer Database indicated that a lower threshold is needed for male patients with early stage ER-positive breast cancer to predict mortality.

PRS-343, a HER2/4-1BB targeting bispecific construct, is well-tolerated and demonstrated anti-tumor activity in heavily pre-treated patient population across multiple tumor types.

MCLA-128 showed radiological and clinical responses in patients with certain types of cancer who harbored neuregulin 1 gene fusions.

Treatment with trastuzumab emtansine demonstrated similar overall survival across 3 treatment arms of patients with HER2‐positive metastatic breast cancer.