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FDA approval (companion diagnostic) · Natera · Oncology

Signatera CDx

A ctDNA test now selects muscle-invasive bladder cancer patients for adjuvant atezolizumab.

CompareFDA approval notice
Approved · PMA

Signatera CDx

Natera · Oncology

Type
Diagnostic test
FDA route
Premarket approval (PMA)
Bottom line for your practice
60s read

After cystectomy for muscle invasive bladder cancer, a positive Signatera CDx result identifies patients eligible for adjuvant atezolizumab. Patients who test negative should continue serial testing until a positive result or the end of the recommended 12-month testing window.

What it is
A companion diagnostic that identifies patients with muscle invasive bladder cancer who have circulating tumor DNA molecular residual disease (ctDNA MRD) after cystectomy. In the supporting trial, MRD was detected by serial ctDNA evaluation of blood.
Indicated for
Patients with muscle invasive bladder cancer after cystectomy who have ctDNA molecular residual disease, to select them for adjuvant treatment with Tecentriq or Tecentriq Hybreza.
What changes
The notice does not compare the test with another way of selecting patients. The supporting trial compared atezolizumab with placebo in patients whose MRD was detected by serial ctDNA testing.
Evidence
Placebo-controlled randomized trialIMvigor011 (NCT04660344) · n=250Median disease-free survival was 9.9 months with atezolizumab vs. 4.8 months with placebo (HR 0.64; 95% CI: 0.47, 0.87; p-value 0.0047). Median overall survival was 32.8 months vs. 21.1 months (HR 0.59; 95% CI: 0.39, 0.90; p-value 0.0131).Randomized against placebo: shows that it works, not how it compares with existing treatments.
Watch for
The notice gives no sensitivity, specificity or false result figures for the test. Patients with negative results should continue serial testing until a positive result or completion of the recommended 12-month testing window. The treatment the test selects for carries warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicity.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
Premarket approval (PMA). The FDA's most demanding device review, for Class III devices that sustain life or carry the highest risk. It requires valid scientific evidence of safety and effectiveness, usually clinical studies, which are not always randomized.

Clinical summary

A circulating tumor DNA assay approved as a companion diagnostic to select patients with muscle-invasive bladder cancer who have ctDNA molecular residual disease after cystectomy for adjuvant atezolizumab, which was approved for this use the same day. In IMvigor011 (250 patients with ctDNA-detected residual disease), 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.

From the source 5

FDA approval notice

The FDA approval notice's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. Today, the FDA also approved Signatera CDx (Natera, Inc.) as a companion diagnostic device to select patients with MIBC after cystectomy who have ctDNA MRD for adjuvant treatment with Tecentriq or with Tecentriq Hybreza.

    Backs · Pathway PMA (FDA approved the test as a companion diagnostic); intended use population

  2. Efficacy was evaluated in IMvigor011 (NCT04660344), a multi-center, randomized, double-blind, placebo-controlled trial enrolling 250 patients with MIBC who had radical cystectomy with lymph node dissection and in whom MRD was detected by serial ctDNA MRD evaluation of blood during the subsequent 12 months, starting at least 6 weeks after cystectomy.

    Backs · IMvigor011, randomized, double-blind, placebo-controlled, n = 250; serial ctDNA evaluation of blood over 12 months

  3. A statistically significant improvement in DFS was observed with atezolizumab compared to placebo, with a median DFS of 9.9 months (95% confidence interval [CI]: 7.2, 12.7) for atezolizumab vs. 4.8 months (95% CI: 4.1, 8.3) for placebo (hazard ratio [HR] 0.64 [95% CI: 0.47, 0.87]; p-value 0.0047).

    Backs · DFS 9.9 vs 4.8 months, HR 0.64 (0.47, 0.87), p 0.0047

View all 5 lines

  1. A statistically significant improvement in OS was also observed, with a median OS of 32.8 months (95% CI: 27.7, not estimable [NE]) and 21.1 months (95% CI: 14.7, NE) in the respective arms (HR 0.59 [95% CI: 0.39, 0.90]; p-value 0.0131).

    Backs · OS 32.8 vs 21.1 months, HR 0.59 (0.39, 0.90), p 0.0131

  2. Patients with negative Signatera CDx test results should continue with serial testing until a positive test result or completion of the recommended 12-month testing window.

    Backs · Negative results: continue serial testing through the 12-month window

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