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The US FDA has granted an accelerated approval to mobocertinib for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The drug is limited to use in patients whose disease has progressed on or after platinum-based chemotherapy and who have had the EGFR exon20 insertion mutation detected on an FDA-approved test. Mobocertinib is the first oral tyrosine kinase inhibitor (TKI) specifically designed to target these mutations, which are less common than the more predominant EGFR mutations in this lung cancer. The most common adverse reactions (> 20%) were diarrhea, rash, nausea, stomatitis, vomiting, decreased appetite, paronychia, fatigue, dry skin, and musculoskeletal pain, according to the company. The prescribing information includes a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.

Source: Medscape

The US FDA has approved the Vivistim System (MicroTransponder), a first-of-its kind vagus nerve stimulation (VNS) system intended to treat moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke. The Vivistim® System stimulates the vagus nerve while the patient is undergoing a rehabilitative movement, which tells the brain to “pay attention” to that movement. This simultaneous pairing of a specific movement with vagus nerve stimulation (VNS) strengthens motor circuits associated with the physical movement. Consistently pairing VNS with specific neural circuits helps rebuild those circuits and the brain relearns the commands to enable the muscles to perform specific tasks and can strengthen those muscles as well. This simultaneous pairing of muscle movement with VNS strengthens the neural circuits in the brain. Over time, a patient may regain upper limb function.

Source: MicroTransponder

The approval covers all three brivaracetam (BRIVIACT) formulations (tablets, oral solution, and IV) and marks the first time the IV formulation will be available for children.

Dosage:

• Dose for adults (16 Years and Older): The recommended starting dosage for monotherapy or adjunctive therapy is 50 mg twice daily (100 mg per day). Based on individual patient tolerability and therapeutic response, the dosage may be adjusted down to 25 mg twice daily (50 mg per day) or up to 100 mg twice daily (200 mg per day).
• Pediatric Patients (1 Month to less than 16 Years): The recommended
  dosage is based on body weight and is administered orally twice daily.

Adverse reaction: Most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) are somnolence/sedation, dizziness, fatigue, and nausea/vomiting.

Source: UCB

The US Food and Drug Administration has approved Medtronic’s Evolut FX system for transcatheter aortic valve replacement (TAVR) in patients with symptomatic severe aortic stenosis at all risk levels. The Evolut FX system features a self-expanding, supra-annular valve and is designed to enhance ease-of-use and provide greater precision and control throughout the procedure. The fourth-generation device is equipped with gold markers built into the frame to provide direct visualization of depth and valve leaflet location during implant.

Source: Medscape

The US Food and Drug Administration (FDA) has expanded indication for the noninvasive BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMSTM) System to include treatment of comorbid anxiety symptoms in adult patients with depression, the company has announced. The neurostimulation system has previously received FDA approval for treatment-resistant major depression, obsessive-compulsive disorder, and smoking addiction.

Source: Medscape