martes, 30 de junio de 2020

FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

https://www.fda.gov/news-events/press-announcements/fda-approves-breast-cancer-treatment-can-be-administered-home-health-care-professional?utm_campaign=FDA%20Approves%20Breast%20Cancer%20Treatment%20That%20Can%20Be%20Administered%20At%20Home%20By%20Health%20Care%20Professional&utm_medium=email&utm_source=Eloqua
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FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

The U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test.

HER2-positive breast cancer, which makes up approximately one-fifth of breast cancers, has too much of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Pertuzumab and trastuzumab bind to sites on HER2 and disrupt signaling to stop cancer cell growth. Phesgo is initially used in combination with chemotherapy and could continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished.

Prescribing information for Phesgo includes a boxed warning to advise health care professionals and patients about the risk of potential heart failure, fetal harm and lung toxicity. Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab.

The most common side effects for patients taking Phesgo were alopecia (hair loss), nausea, diarrhea, anemia (reduced number of red blood cells) and asthenia (lack of energy). Phesgo can cause worsening of chemotherapy induced neutropenia (low level of white blood cells).

Women who are pregnant should be advised that Phesgo may cause harm to a developing fetus or a newborn baby. The FDA advises health care professionals to inform females of reproductive age that exposure to Phesgo during pregnancy or within 7 months prior to conception can result in fetal harm.

Patients who experience anaphylaxis (severe allergic reaction) or severe hypersensitivity should discontinue Phesgo.

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