Biologics

Kite’s Tecartus for Mantle Cell Lymphoma Gets Full Approval

FDA has granted full approval for Kite’s CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell lymphoma (MCL), converting its prior accelerated approval into a traditional approval based on confirmatory clinical data.

The decision is based on updated results from the ZUMA-2 study, including new data from Cohort 3, which evaluated patients who had not previously received Bruton tyrosine kinase inhibitors (BTKi), according to the company. FDA ruled that the totality of evidence — including efficacy, safety, and pharmacokinetics — demonstrated high response rates, durable remissions, and a safety profile consistent with earlier findings, it says.

The approval fulfills Kite’s post-marketing requirement under the accelerated approval pathway, which required verification of clinical benefit in a confirmatory trial. With the inclusion of Cohort 3 data in the label, Tecartus is now positioned for use earlier in the treatment sequence, including in patients who are BTKi-naive.

Kite says the clinical data from ZUMA-2 showed strong outcomes across patient groups. In heavily pretreated patients (Cohort 1), the therapy achieved an overall response rate (ORR) of 87% and a complete remission rate of 62%. In the less heavily treated, BTKi-naive population (Cohort 3), ORR reached 91% with a 79% complete remission rate. Median duration of response had not yet been reached in either cohort, suggesting sustained benefit over time.

Mantle cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma that primarily affects older adults and is often difficult to treat after relapse.

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