Drugs

Genentech’s Tecentriq OK’d for Muscle-Invasive Bladder Cancer

FDA has approved Genentech’s Tecentriq (atezolizumab) and a subcutaneous formulation of the drug for the adjuvant treatment of certain patients with muscle-invasive bladder cancer who test positive for circulating tumor DNA after surgery. The approval covers adults with muscle-invasive bladder cancer who have undergone cystectomy and are found to have molecular residual disease using a concurrently authorized circulating tumor DNA (ctDNA) test —Natera’s Signatera CDx.

The PD-L1 blocking immunotherapy’s approval was based on data from the Phase 3 IMvigor011 study, which enrolled 250 patients with muscle-invasive bladder cancer whose blood tests showed ctDNA residual disease following bladder removal surgery.

Patients receiving atezolizumab experienced a statistically significant improvement in disease-free survival compared with placebo, FDA said. Median disease-free survival was 9.9 months in the treatment arm versus 4.8 months for placebo.

The study also demonstrated an overall survival benefit. Median overall survival was 32.8 months for patients receiving atezolizumab compared with 21.1 months in the placebo group.

FDA said the drug labeling includes warnings for immune-mediated adverse reactions, infusion-related reactions, transplant complications and embryo-fetal toxicity.

The approved intravenous dosing options include administration every two, three or four weeks for up to one year unless disease recurrence or unacceptable toxicity occurs. The subcutaneous Tecentriq Hybreza formulation may be administered every three weeks for up to one year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome