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Diagnostics

Signatera CDx

Natera · FDA approval (companion diagnostic)

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

Clinical summary

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.

Read the primary source: FDA approval notice

More innovations

Medical Devices

Optune Pax

Novocure · FDA premarket approval

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

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.

OncologyView Innovation
Diagnostics

SimpleScreen CRC

Freenome · FDA approval

A second blood-based colorectal cancer screening test reaches the US market.

A cell-free DNA blood test for colorectal cancer screening in average-risk adults aged 45 and older, commercialized in the US by Abbott. In PREEMPT CRC (more than 48,000 participants), sensitivity for colorectal cancer was 81.1% and specificity 90.4%, but sensitivity for advanced precancerous lesions was only 13.7%. A positive result must be followed by colonoscopy, and the test does not replace colonoscopy in high-risk patients.

GastroenterologyView 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