First! FDA approves rare adrenal tumor therapy.

Recently, the U.S. Food and Drug Administration (FDA) approved Azedra (IOBEGUUNI I 131) for the treatment of rare adrenal tumors that cannot be surgically removed and require systemic anti-cancer treatment, mainly for adults and adolescents 12 years of age and older.
note that this is the first time the FDA has approved a drug for this purpose.
these glands are located just above the kidneys, and hormones, including hormones, are called epinephrine and norepinephrine. In some rare cases, patients develop pheromocytomas or paraganglioma, which affects the normal function of the adrenal glands, leading to excessive production of hormones, triggering a range of symptoms such as high blood pressure, headache, and excessive heart rate. Because of the specificity of tumor location, not all patients can surgically remove these tumors. They also need a systematic treatment.
the new drug's effectiveness was validated in a one-arm, publicly labeled clinical trial. The trial recruited 68 patients,
15 (22%) received overall tumor remission and 17 (25%) reduced their use of antihypertensive drugs by 50% or more over a period of at least six months.
this also reaches the main clinical endpoint of the study.the most common serious side effects in clinical trials
AZEDRA patients include lymphocyte reduction, neutrophil reduction, platelet reduction, fatigue, anemia, and increased international. Laboratory tests to measure blood clotting, nausea, dizziness, high blood pressure, and vomiting.
Because it is a radioactive therapeutic agent, Azedra includes warnings about radiation exposure to patients and their families, and when patients receive Azedra, radiation should be minimized. Other warnings and precautions include reduced blood cell levels (bone marrow suppression), hypothyroidism, elevated blood pressure, kidney failure or kidney damage and pneumonia. Myelocinim hyperplasia syndrome and acute leukemia were observed in patients receiving AZEDRA, and the size of this risk will continue to be studied. AZEDRA can cause harm to a developing fetus, and women should inform the fetus of the potential risks and use effective methods of contraception after receiving Azedra. Radiation exposure associated with AZEDRA can lead to male and female infertility.
"Many ultra-rare cancer patients can be treated with surgery or topical treatment, but for patients experiencing tumor-related symptoms such as high blood pressure, there is no effective systematic treatment." Dr Richard Pazdur, director of the FDA Cancer Center, said: "Now patients will receive approved treatment, which suggests that the need for blood pressure drugs is reduced in some patients and the size of the tumor is reduced."
FDA approval of AZEDRA to sub-pharmaceutical companies. (Yang Liping/Compilation)
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