Drugs

Lantheus Gets ‘Complete Response’ Letter for Tumor Imaging Agent

FDA has issued Lantheus a Complete Response Letter (CRL) for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emission tomography (PET) imaging agent for detecting neuroendocrine tumors (NETs). According to the company, the agency letter said it could not approve the application until inspection-related deficiencies at a third-party drug product manufacturing facility are resolved.

Lantheus emphasized that the FDA's action was unrelated to the clinical data supporting the application. The company said the CRL identified no concerns regarding the safety or efficacy of LNTH-2501 and raised no issues with the data submitted in support of the NDA.

"We remain confident in LNTH-2501 and are committed to bringing this imaging agent to NET patients and healthcare providers as soon as possible," CEO Mary Anne Heino said in a statement. She added that the FDA's feedback relates solely to the company's third-party manufacturing partner and that Lantheus is working with both the manufacturer and the agency to address the outstanding facility issues.

LNTH-2501 is an investigational kit used to prepare gallium-68 edotreotide injection for PET imaging of somatostatin receptor-positive neuroendocrine tumors in adult and pediatric patients. The product is designed to allow radiopharmacies to prepare the imaging agent using gallium-68 obtained from an on-site generator.

The setback highlights the continued impact that manufacturing and facility compliance issues can have on regulatory reviews. Lantheus did not provide a timeline for resubmitting the application.

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