Drugs

FDA Rejects Genentech’s Bid to Expand Columvi Use

FDA has rejected Genentech’s move to broaden the use of its lymphoma drug Columvi (glofitamab-gxbm). The agency issued the company a complete response letter rejecting its supplemental BLA to expand Columvi’s use in combination with chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for stem cell transplant.

In the letter, FDA concluded that the data from the STARGLO Phase 3 trial, which evaluated Columvi in combination with gemcitabine and oxaliplatin (GemOx), did not provide sufficient evidence to support approval for this earlier treatment setting, according to the company. It says the STARGLO trial showed a 41% reduction in the risk of death compared to a standard treatment arm, results that were recently published in The Lancet. The trial was also intended to serve as a confirmatory study to convert Columvi’s existing accelerated approval in third-line or later DLBCL into full approval.

Genentech says Columvi will remain available under its current accelerated approval for patients who have received two or more prior treatments for DLBCL. It says it is continuing discussions with FDA and is now looking to its ongoing SKYGLO Phase 3 study, which is evaluating Columvi in combination with Polivy, Rituxan, and standard chemotherapy in untreated DLBCL, as a potential new confirmatory trial to fulfill postmarketing requirements.

The company describes Columvi as a bispecific antibody designed to engage T-cells to target malignant B-cells in patients with blood cancers. DLBCL is the most common type of non-Hodgkin’s lymphoma worldwide, with up to 40% of patients relapsing after initial treatment, it adds.

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