FDA approves blood test to aid in Alzheimer's diagnosis

Recalls and warnings

A class I recall by BD updating instructions for esophagogastric balloon tamponade tubes. BD is aware that users are sometimes unable or find it difficult to remove the plastic plugs from the rubber lumen to inflate the gastric and/or esophageal balloons. In some cases, the devices may become damaged during removal of the plastic plugs and a replacement device may be needed. BD has reported two serious injuries and one death associated with this issue.

An FDA- and CDC-recommended pause of the chikungunya vaccine (IXCHIQ) in individuals ages 60 years and older while the agencies investigate postmarketing reports of serious adverse events, including neurologic and cardiac events. As of May 7, 17 serious adverse events, including two that resulted in death, have been reported in individuals ages 62 through 89 years, six in the United States. Most of the serious adverse events that have been reported to the Vaccine Adverse Event Reporting System have been in patients with underlying chronic medical conditions.

A drug safety communication that patients stopping cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching.

Approvals

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first in vitro device that tests blood to aid in diagnosing Alzheimer's disease by providing early detection of amyloid plaques in adults ages 55 years and older with Alzheimer's signs and symptoms. In a multicenter clinical study of 499 individual plasma samples from adults with cognitive impairment, 91.7% of those with positive test results had amyloid plaques confirmed on positron emission tomography (PET) or cerebrospinal fluid (CSF) testing and 97.3% of those with negative results had negative PET or CSF results. Fewer than 20% of those tested had an indeterminate result.

Nuvaxovid, a Novavax vaccine to prevent COVID-19 in adults ages 65 years and older and for individuals ages 12 through 64 years with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes. The vaccine previously had emergency authorization for people ages 12 years and older.

mNEXSPIKE, a Moderna COVID-19 vaccine indicated for all adults ages 65 years and older and individuals ages 12 to 64 years with at least one underlying risk factor for COVID-19 who have received a previous COVID-19 vaccine.

Accelerated approval for avutometinib and defactinib (Avmapki Fakzynja co-pack) for adults who have KRAS-mutated recurrent low-grade serous ovarian cancer and have received prior systemic therapy. An open-label multicenter trial found a confirmed overall response rate of 44%, with duration of response ranging from 3.3 to 31.1 months. The most common adverse reactions were increased creatine phosphokinase and aspartate aminotransferase levels, nausea, and fatigue, among others. The treatment received an orphan-drug designation.

Belzutifan (Welireg) for patients ages 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). The treatment is the first FDA-approved oral therapy for PPGL. An open-label multicohort trial of 72 patients found an overall response rate of 26% and a median duration of response of 20.4 months. Common adverse reactions included anemia, fatigue, musculoskeletal pain, and decreased lymphocytes, among others.

Accelerated approval of telisotuzumab vedotin-tllv (Emrelis), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, nonsquamous non-small-cell lung cancer with high c-Met protein overexpression, as determined by an FDA-approved test, who have received prior systemic therapy. The FDA also approved the VENTANA MET RxDx assay as a companion diagnostic test. A multicenter open-label trial found an overall response rate of 35% and a median duration of response of 7.2 months. The most common adverse reactions were peripheral neuropathy, fatigue, decreased appetite, and peripheral edema.

Retifanlimab-dlwr (Zynyz) with carboplatin and paclitaxel for first-line treatment of adults with inoperable locally recurrent or metastatic squamous-cell carcinoma of the anal canal (SCAC). Retifanlimab-dlwr was also approved as a single agent for adults with locally recurrent or metastatic SCAC with disease progression on, or intolerance to, platinum-based chemotherapy. A randomized multicenter trial found that median progression-free survival was 9.3 months in the retifanlimab-dlwr arm and 7.4 months in the placebo arm. The treatment received an orphan-drug designation. The prescribing information includes warnings and precautions for severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem-cell transplantation, and embryo-fetal toxicity.