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FDA Approves New Treatment for HER2-Positive Breast Cancer

Confirmed

Health Desk

In Short: The FDA has approved tucatinib (Tukysa, Pfizer) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

Positive immunohistochemistry of KI-67 in invasive breast cancer
Photo: Sandi Shen, Gaofang Xiao, Richang Du, Ningdong Hu, Xu Xia and Haibo Zhou / Wikimedia Commons (CC BY 3.0)

The FDA has approved tucatinib (Tukysa, Pfizer) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

Patients were randomly assigned evenly to receive tucatinib 300 mg or placebo orally twice daily on a background of trastuzumab and pertuzumab.

Overall, 42% of tucatinib patients experienced grade ≥ 3 adverse events compared to 24% in the placebo group; 13% of tucatinib subjects discontinued treatment due to adverse events, primarily hepatic side effects.

Tucatinib is already approved in combination with trastuzumab and capecitabine for HER2-positive advanced unresectable or metastatic breast cancer, including patients with brain metastases, after one or more prior anti-HER2 breast cancer treatments in the metastatic setting.

Hormone receptor-positive patients were allowed to continue endocrine therapy.

The trial 'puts exercise in a whole new evidentiary category,' according to Kathryn H., highlighting the importance of structured support in cancer treatment.

In the U.S. PATHFINDER 2 study, Galleri detected 35% of cancers diagnosed in participants during the following 12 months.

Researchers studying a widely used form of cancer immunotherapy found that certain diets normally associated with weight gain actually helped the treatment work better in mice.

'There is a synergistic relationship between the bacteria that reside in our GI tract, and the food we eat,' said Quail, Associate Professor in the Department of Physiology and Principal Investigator at the Rosalind & Morris Goodman Cancer Institute.

Alzheimer's patients on glucosamine also had a 25 percent higher risk of death, according to a study using AI to analyze more than a decade of patient health records from the UF Health system.

What this adds

The study involving tucatinib and its combination therapies adds to the growing body of research on targeted cancer treatments.

The PATHFINDER 2 study's results provide a benchmark for evaluating the effectiveness of new cancer detection technologies.

The dietary findings suggest potential new avenues for enhancing the efficacy of cancer treatments through diet modification.

Background

According to Oren Milstein, CEO of StemRad, a single major solar particle event can deliver more than one-third of NASA’s 600 millisievert career effective-dose limit, which corresponds to a 3% mortality risk from radiation-induced cancer.

What's confirmed

What's still developing

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