FDA Approves New Roche Drug Uses for Cancer, Kidney and Eye Diseases

The U.S. Food and Drug Administration (FDA) approved new uses for Roche medicines in kidney disease, colon cancer and thyroid eye disease, with decisions spanning Sept. 25 to Oct. 15.

On Oct. 8, the FDA cleared Tecentriq with fluoropyrimidine and oxaliplatin as an adjuvant regimen for patients at least 2 years old with stage III colon cancer and mismatch repair deficiency. The agency also approved Tecentriq Hybreza with the same chemotherapy for patients ages 12 and older who weigh at least 40 kilograms.

In the phase III ATOMIC trial, three-year disease-free survival was 86.3% for patients who received atezolizumab with mFOLFOX6, compared with 76.2% for those who received mFOLFOX6 alone. Median follow-up was 40.9 months.

The FDA approved Enspryng for adults with thyroid eye disease on Oct. 15. Patients or caregivers can administer the treatment under the skin at home after training from a health care provider.

On Sept. 25, the FDA cleared Gazyva to reduce relapse risk for patients at least 2 years old who are in complete remission from frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome. It was the only one of the three approval decisions made before Roche’s quarter ended Sept. 30.