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Medical Devices

Optune Pax

Novocure · FDA premarket approval

A wearable Tumor Treating Fields device for locally advanced pancreatic cancer.

Clinical summary

A portable, non-invasive device that delivers alternating electric fields (Tumor Treating Fields) to the abdomen to disrupt cancer cell division, worn alongside gemcitabine plus nab-paclitaxel in adults with locally advanced pancreatic cancer. In the PANOVA-3 trial it extended overall survival by about two months over chemotherapy alone. Skin reactions under the transducer arrays were the most common device-related adverse event.

Read the primary source: FDA press release

More innovations

Diagnostics

Signatera CDx

Natera · FDA approval (companion diagnostic)

A ctDNA test now selects bladder cancer patients for adjuvant immunotherapy.

A tumor-informed circulating tumor DNA assay approved to identify patients with muscle-invasive bladder cancer who are ctDNA-positive after cystectomy and eligible for adjuvant atezolizumab, approved for this use the same day. In IMvigor011 (250 ctDNA-positive patients), atezolizumab improved median disease-free survival (9.9 vs 4.8 months; HR 0.64) and overall survival (32.8 vs 21.1 months; HR 0.59) versus placebo.

OncologyView Innovation
Medical Devices

TECNIS PureSee IOL

Johnson & Johnson · FDA premarket approval

An extended-depth-of-focus IOL with contrast comparable to a monofocal.

A purely refractive extended-depth-of-focus intraocular lens for primary implantation after cataract removal in adults with less than 1 diopter of corneal astigmatism. Contrast sensitivity was comparable to an aspheric monofocal IOL, and 97% of patients reported no very bothersome halos or glare. Labeling excludes several ocular comorbidities, including uncontrolled glaucoma, macular disease and diabetic retinopathy.

OphthalmologyView Innovation
Drugs

Juvmo (tavapadon)

AbbVie · FDA approval

First selective D1/D5 dopamine agonist approved for Parkinson's disease.

A once-daily oral tablet for adults with Parkinson's disease, with or without levodopa; unlike existing agonists, which act mainly on D2/D3 receptors, it selectively activates D1/D5. In TEMPO-3, as adjunct to levodopa in patients with motor fluctuations, daily 'on' time without troublesome dyskinesia rose by 1.7 hours versus 0.6 hours with placebo. Warnings include orthostatic hypotension, hallucinations, dyskinesia and impulse-control urges.

NeurologyView Innovation