FDA Policy/General

Plus Therapeutics Gets Orphan Statis for Radiotherapy

FDA has granted Plus Therapeutics an orphan drug designation to Rhenium (186Re) Obisbemeda, a radiotherapy for treating leptomeningeal metastases (LM) in patients with lung cancer. The designation is based on data from the ReSPECT-LM Phase 1 single-dose trial, according to the company. It is now advancing the therapy into a Phase 2 single-dose expansion trial and a Phase 1 multiple-dose trial while discussing with FDA an optimal pivotal trial strategy, it adds.

LM is a rare cancer complication where the primary cancer spreads to the cerebrospinal fluid (CSF) and leptomeninges surrounding the brain and spinal cord. “All malignancies originating from solid tumors, primary brain tumors, or hematological malignancies have this LM complication potential with breast cancer as the most common cancer linked to LM, with 3-5% of breast cancer patients developing LM,” Plus Therapeutics says.

The radiotherapy is designed to deliver highly targeted high dose radiation to tumors in a safe, effective and convenient manner to optimize patient outcomes, the company says. Rhenium (186Re) obisbemeda has the “potential to reduce risks and improve outcomes for CNS [central nervous system] cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose,” Plus Therapeutics says. “Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue and gamma energy for live imaging.”

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