Updates ·
Health notices · Tuesday 20 October
3 notices from the agencies today, in plain words, each with the original linked.
FDA approval for Imbruvica (ibrutinib) for several cancers and cGVHD
Food and Drug Administration (FDA) · Approval
If you have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), the FDA approval means Imbruvica may be an option for treatment.
It may also be used for adults with CLL/SLL with 17p deletion and for adults with Waldenström’s macroglobulinemia (WM).
Imbruvica is also approved for adults and children age 1 year and older with chronic graft-versus-host disease (cGVHD) after failure of one or more systemic therapies.
CDC updates guidance on diagnosing breast cancer
Centers for Disease Control and Prevention (CDC) · Guidance
If you have had a screening mammogram that looks abnormal, doctors use more tests to find out whether it is breast cancer (or rule it out). This may include seeing a breast specialist or surgeon.
Tests may include ultrasound, a diagnostic mammogram with more detailed x-ray pictures, magnetic resonance imaging (MRI), and a biopsy. A biopsy removes a small tissue or fluid sample to check for cancer cells under a microscope.
If breast cancer is diagnosed, additional tests are done to “stage” it—find out whether cancer cells have spread within the breast or to other parts of the body. The cancer type and stage help guide treatment decisions.
What to do
- Talk to your doctor about when to start and how often to get a mammogram.
FDA approves Testosterone Cypionate injection for testosterone replacement
FDA · Approval
If you are a man with symptoms of low testosterone due to deficiency or absence of your body’s own testosterone, the FDA has approved Testosterone Cypionate injection for replacement therapy.
This approval covers specific causes of primary hypogonadism (such as testicular failure or after removal of the testicles) and hypogonadotropic hypogonadism (including pituitary/hypothalamus causes).
It does not establish safety or effectiveness for “age-related hypogonadism,” also called “late-onset hypogonadism.”