Drugs

FDA Approves Progenics’ Azedra for Adrenal Tumors

FDA has approved Progenics Pharmaceuticals’ Azedra (iobenguane) injection for IV use to treat adults and adolescents age 12 and older with pheochromocytoma or paraganglioma tumors that are unresectable, have spread beyond the original tumor site, and require systemic anticancer therapy. An agency statement says this is the first FDA-approved drug for this use.

Azedra’s efficacy was shown in a single arm clinical trial in 68 patients that measured the number of patients who experienced a 50% or greater reduction of all antihypertensive medications for at least six months. The statement says the primary endpoint was supported by the secondary endpoint of overall tumor response, measured by traditional imaging criteria. The study reportedly met the primary endpoint with 25% of the patients experiencing a 50% or greater reduction of all antihypertensive medication for at least six months. Overall tumor response was achieved in 22% of the patients studied.

The most common reported side effects were lymphopenia, neutropenia, thrombocytopenia, fatigue, anemia, increased international normalized ratio, nausea, dizziness, hypertension, and vomiting.

As it is a radioactive therapeutic agent, FDA says, Azedra includes a Warning about radiation exposure to patients and family members, which should be minimized while the patient receives Azedra.

The application received Fast Track, Breakthrough Therapy, Priority Review, and Orphan Drug designations.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome