Drugs

Roche Priority Review BLA for B-cell Lymphoma

FDA has accepted a Roche BLA for priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. FDA has set a user fee review action target date of 7/1. “If approved, glofitamab would be the first fixed-duration, off-the-shelf CD20xCD3 T-cell engaging bispecific antibody available to treat people with an aggressive lymphoma who have previously received multiple courses of treatment,” the company says.

The BLA is based on positive data from the pivotal Phase 1-2 NP30179 study, which showed that 40% of patients achieved a complete response (CR) and 51.6% achieved an objective response. “Among those who achieved a CR, 73.1% continued to experience a response at 12 months, while the median duration of CR was not reached,” the company says. “The median duration of response was 18.4 months.”

The most common adverse event was cytokine release syndrome (CRS), which was mostly low grade, Roche says. Most of the events were associated with glofitamab’s initial administration of glofitamab (in cycle 1), adding that only one patient discontinued therapy due to CRS.

Glofitamab is engineered to have one region that binds to CD3, a protein on T-cells, and two regions that bind to CD20, a protein on B-cells, according to the company. “This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell,” 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