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The FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki, a new drug for treating HER2-positive unresectable or metastatic breast cancer in adults.

The Food and Drug Administration (FDA) has given accelerated approval to a new drug called fam-trastuzumab deruxtecan-nxki. This drug is for adults who have a type of breast cancer known as HER2-positive that is either unresectable (cannot be removed by surgery) or metastatic (has spread to other parts of the body). The approval was granted on April 5, 2024.

Fam-trastuzumab deruxtecan-nxki is intended for patients who have already tried other treatments that didn’t work well. This drug works by targeting and attacking cancer cells that have a protein called HER2 on their surfaces. It is part of a group of drugs known as antibody-drug conjugates, which combine a targeted therapy with chemotherapy to help kill cancer cells more effectively.

The FDA’s decision was based on a clinical trial that showed promising results. In this trial, patients who took fam-trastuzumab deruxtecan-nxki experienced a significant reduction in tumor size. Some patients even saw their cancer stop growing for a period of time. The most common side effects included nausea, fatigue, and low levels of certain blood cells.

The FDA used an accelerated approval process to make this drug available more quickly because it fills an unmet medical need. This means that the drug can be prescribed to patients while more data is collected to confirm its benefits and safety.

The approval of fam-trastuzumab deruxtecan-nxki offers new hope for patients with HER2-positive breast cancer who have not had success with other treatments. This development is an important step forward in the fight against this aggressive form of cancer.

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