Enhertu (trastuzumab deruxtecan) has been granted conditional approval in the U.K. for the treatment of adults with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. A conditional approval is given to therapies whose benefit of immediate availability outweighs the risk of having less comprehensive data. Still, regulators require additional data or testing before granting full approval. The decision of the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. follows a similar ruling in the European Uni ..read more

An open-label Phase 2 clinical trial will test the safety and efficacy of IRX-2, an experimental immunology-based cancer therapy, in combination with Keytruda (pembrolizumab) and chemotherapy. The study is enrolling adults with triple-negative breast cancer (TNBC) — cancers not driven by the hormones progesterone or estrogen, or by the protein HER2 — according to the therapy’s developer, Brooklyn ImmunoTherapeutics. Already underway at the Providence Cancer Institute, in Portland, Ore., the trial (NCT04373031) is expected to enroll about 30 patients with locally confirmed triple-negative ..read more

Seagen’s Tukysa (tucatinib) has been approved by the European Commission (EC) as part of a triple-combination therapy for people with previously treated advanced or metastatic HER2-positive breast cancer. The EC approved Tukysa, when given alongside trastuzumab and the chemotherapy medication Xeloda (capecitabine), for patients who have received at least two anti-HER2-based treatments for metastatic disease. With this decision, Seagen — previously known as Seattle Genetics — will be able to market the Tukysa combo in all European Union (EU) member states, plus Norway, Liechtenstein ..read more

The first participant has been dosed in the Phase 2 clinical trial TENACITY, which is evaluating Ayala Pharmaceuticals‘ investigational therapy AL101 as a treatment for Notch-activated recurrent or metastatic triple negative breast cancer (TNBC). AL101 is an investigational small molecule that inhibits Notch proteins. This family of cellular proteins plays important roles in governing cell growth during development. In some cancers, however, abnormal Notch signaling helps to facilitate cancer growth and survival. “We believe the need for a novel therapeutic option is critical as Notch-activa ..read more

After promising results from patients enrolled to date, Atossa Therapeutics halted an Australian Phase 2 clinical trial evaluating its investigative oral therapy Endoxifen in women newly diagnosed with invasive, estrogen receptor (ER)-positive breast cancer and scheduled for surgery. “It is a welcome event to halt an ongoing clinical trial because the results are so overwhelmingly positive,” Steven Quay, MD, PhD, Atossa’s president and CEO, said in a press release. Interim data showed that the therapy resulted in clinically meaningful reductions in tumor activity prior to surgery in each of ..read more

Theralink Technologies announced that it has begun testing its new profiling biomarker assay — a test that could potentially provide oncologists with key information about a patient’s specific tumor — in people with breast cancer. “The Theralink assay for breast cancer may reveal therapeutic options for oncologists and in turn, may provide better outcomes for breast cancer patients,” Mick Ruxin, MD, president and CEO of Theralink, said in a press release. The new test uses Reverse Phase Protein Array (RPPA) technology to measure the abundance and activation of hundreds of biomarker proteins ..read more

A national study is seeking women in the U.S. to help determine the safest and best way to screen for breast cancer, and to improve on current guidelines. It’s being conducted at several sites across the country with the aim of enrolling 100,000 women, 40 to 74 years of age, who have not been diagnosed with breast cancer. One site, The O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham (UAB), plans to enroll up to 5,000 women over five years. “This is a unique opportunity for women to participate in a study that can help generations of women to come,” Rachael Lanca ..read more

In honor of World Cancer Day on Feb. 4, the Breast International Group (BIG) emphasized the importance of wide-scale cooperation in efforts to advance cancer research. “None of BIG’s achievements would be possible without the willingness to work together,” stated a press release highlighting some of the clinical trials that are supported by BIG, an international not-for-profit based in Brussels, Belgium, representing more than 50 research groups from around the world. This year’s World Cancer Day theme is “Together, all our actions matter.” “To test new treatments with enough patients to be ..read more

The European Commission has conditionally approved Enhertu (trastuzumab deruxtecan) for adults in the EU with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. A conditional approval is granted when the benefits of a medication regulators say still requires additional data or testing are found to outweigh its potential risks. Such approval is given for therapies whose immediate availability fulfills an unmet medical need, as in the case of advanced HER2-positive breast cancer. Enhertu’s full approval in the European Union ..read more

Imagio, Seno Medical Instruments’ non-invasive and radiation-free breast imaging technology, has been approved for commercialization by the Center for Devices and Radiological Health, part of the U.S. Food and Drug Administration (FDA). The technology — known fully as the Imagio Breast Imaging System — was designed to help physicians better distinguish malignant, or cancerous breast tumors from benign ones. “We are thrilled to have reached this milestone and are looking forward to moving our technology platform forward in the U.S. with this FDA approval,” Tom Umbel, Seno’s CEO, said in ..read more