Marketing OK'd for at-home STI test

Recalls and warnings

A class I recall and updated instructions for embolization devices by Medtronic Neurovascular due to reports of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures. The risks were higher in women, especially those younger than age 45 years. Use of the affected product may cause serious adverse health consequences, including thrombosis, stroke, or death. There have been 13 reported injuries and four reports of death related to the 027-compatible Pipeline Vantage embolization device and four reported injuries related to the 021-compatible Pipeline Vantage embolization device.

A class I recall of ORAL/NASAL endotracheal tubes by Smiths Medical after the company became aware that certain sizes may have a smaller diameter than expected and not provide enough ventilation to the patient. The use of affected product may cause serious adverse health consequences, including hypoxia that may lead to organ failure, laryngeal edema, cardiopulmonary arrest, and death. There have been eight reported injuries.

A class I recall of ProPort plastic implantable ports by Smiths Medical due to a manufacturing defect that may cause the plastic port housing and port reservoir to separate before, during, or after implantation. The use of affected product may cause delay or interruption of life-saving therapies, damage or scarring to skin or tissue surrounding the port from contact with leaking IV medications or air entering the bloodstream. There have been two reported injuries.

A recall of Spectrum infusion pumps by Baxter Healthcare Corporation due to the potential for missing motor mounting screws, which may have occurred during the servicing process. Missing motor mounting screws may lead to insufficient or excessive therapy, interruption in therapy, or delay in therapy, which can result in serious adverse health consequences. The company has reported one serious injury related to this issue.

A class I recall correcting software for the BD Alaris systems manager and BD Care Coordination Engine infusion adapter by Becton, Dickinson and Company, after reports of delayed system response and backlogging of automated programming requests (APRs). Outdated APRs may present different rate, dose, or volume parameters than the current infusion. The use of affected product may cause serious adverse health consequences, including sudden pump stop and too much or too little therapy. There have been no reported injuries.

An alert about a risk of injury during use of the CVAC aspiration system from Calyxo when patients have thick fluid in the kidney at the start of lithotripsy, which can cause reduced fluid outflow that can lead to excessive pressure in the kidney. If the increased pressure in the kidney is not addressed, serious injury or death may occur. One reported death has been associated with this issue.

A recall of certain lots of immune globulin, IV and subcutaneous, due to a higher-than-expected rate of allergic/hypersensitivity reactions, some of which were considered medically significant.

A recall of one batch of levetiracetam in 0.75% sodium chloride injection, 1,000 mg/100 mL (10 mg/mL) single-dose infusion bags by Dr. Reddy's Laboratories Ltd. In lot number A1540076, the infusion bag is incorrectly labeled as levetiracetam in 0.82% sodium chloride injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as levetiracetam in 0.75% sodium chloride injection 1,000 mg/100 mL. No adverse events have been reported.

A warning letter sent to Dexcom, Inc., stating that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the G6 and G7 continuous glucose monitors are not in conformity with the current good manufacturing practice requirements of the Quality System regulation. Violations included inadequate process monitoring and test validation.

Classwide labeling changes for testosterone products to include a new warning about the risk of increased blood pressure on testosterone products that currently do not contain such labeling information.

Miscellaneous

The addition of dialysis bloodlines to the Medical Device Shortages List. The disruption in the availability of this device may require adjustments to the clinical management of patients requiring acute or chronic hemodialysis. The FDA recommends health care professionals experiencing delays in the supply of hemodialysis bloodlines consider strategies to conserve their use. The agency recently removed blood culture media bottles and IV containers from the shortages list.

Approvals

Marketing authorization of Visby Medical's women's sexual health test, the first at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription. The test is intended for women with or without symptoms and delivers results in approximately 30 minutes. The single-use test includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates to the Visby Medical app and displays results when the test is complete. In women with and without symptoms, the test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples. Risks associated with this test include the possibility of false positive and false negative test results.

Fitusiran (Qfitlia) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients 12 years of age and older with hemophilia A or hemophilia B, with or without factor VIII or IX inhibitors. Two trials found a 73% reduction in estimated annualized bleeding rate in patients with inhibitors who received fitusiran compared to those who received on-demand treatment with bypassing agents. In participants without inhibitors, there was a 71% reduction versus on-demand treatment with clotting factor concentrates. The treatment, an orphan drug, carries a boxed warning for thrombotic events and gallbladder disease, and an additional warning about liver toxicity. Common side effects include viral infection, nasopharyngitis, and bacterial infection.

A new indication for tenecteplase (TNKase) to treat acute ischemic stroke in adults. The most common adverse reaction is bleeding. It is delivered as a single five-second IV bolus.

Cabozantinib (Cabometyx) for patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET). A placebo-controlled multicenter trial found that in the pNET cohort median progression free survival was 13.8 months in the cabozantinib arm and 3.3 months in the placebo arm, and overall response rates were 18% and 0, respectively. In the epNET cohort, median progression free survival was 8.5 months in the cabozantinib arm and 4.2 months in the placebo arm, with respective overall response rates of 5% and 0.

Iptacopan (Fabhalta) for the treatment of adults with complement 3 glomerulopathy (C3G) to reduce proteinuria. C3G is a rare disease that causes inflammation and damage to the kidney glomeruli. Iptacopan is an oral capsule, taken twice daily.

Pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1. Pembrolizumab previously received accelerated approval for this indication in May 2021. A multicenter placebo-controlled trial found a statistically significant improvement in overall survival and progression free survival in patients randomized to pembrolizumab in combination with trastuzumab and chemotherapy compared with placebo in combination with trastuzumab and chemotherapy.

Revakinagene taroretcel-lwey (Encelto) an allogeneic encapsulated cell-based gene therapy for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). MacTel is a rare progressive disease of the macula, leading to degeneration of the photoreceptors. The treatment is administered into the patient's eye during a single surgical procedure performed by a qualified ophthalmologist.

Expanded indication of lutetium Lu 177 vipivotide tetraxetan (Pluvicto) to include adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy. A randomized multicenter trial found median radiographic progression free survival was 9.3 months in the lutetium Lu 177 vipivotide tetraxetan arm and 5.6 months in the ARPI arm.

Durvalumab (Imfinzi) with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer. A randomized multicenter trial found a statistically significant improvement in event free survival and overall survival in patients who received neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery.

Marketing authorization of the CORIS System, the first automated endoscope channel cleaner that uses the CORIS QUANTUM cleaning agent to clean endoscope channels of the Olympus EVIS EXERA III CF-HQ190L colonovideoscope used in colonoscopy. The automated cycle delivers the cleaning agent to all endoscope channels, which are then rinsed and purged with air. All external surfaces of the endoscope must still be cleaned and reprocessed according to the endoscope manufacturer's instructions.

First-time generic drug approvals

Rivaroxaban (Xarelto), 2.5 mg, tablets to reduce the risk of major cardiovascular events in adult patients with coronary artery disease and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower-extremity revascularization procedure due to symptomatic PAD.

Note: The FDA states that drugs are not always commercially available immediately after approval.