Biologics

FDA Wants New Survival Trial Before Compass Files Tovecimig BLA

FDA has recommended that Compass Therapeutics conduct an additional clinical trial demonstrating an overall survival benefit before submitting a BLA for tovecimig and its use in previously treated, advanced biliary tract cancer patients, despite positive response rate and progression-free survival results from the Phase 2/3 COMPANION-002 study, according to the company.

In disclosing the FDA feedback 9/22, Compass says it does not believe another trial is warranted before filing a BLA given the existing clinical data and limited treatment options for patients with advanced biliary tract cancer. The company intends to continue discussions with FDA while preparing its BLA submission, although the agency's recommendation raises uncertainty about the regulatory path forward.

In COMPANION-002, tovecimig, an investigational DLL4 x VEGF-A bispecific antibody, was evaluated in combination with paclitaxel in patients with previously treated, advanced biliary tract cancer. The combination demonstrated a statistically significant improvement in the primary endpoint of objective response rate, achieving an ORR of 18.0% compared with 5.3% for paclitaxel alone, according to the company.

Median progression-free survival was 4.7 months with tovecimig plus paclitaxel versus 2.6 months with paclitaxel alone (HR 0.44; p<0.0001), representing a 56% reduction in the estimated risk of disease progression or death, it adds.

However, the study did not demonstrate a statistically significant overall survival benefit. Compass says the survival analysis was confounded by substantial crossover from the control arm and prolonged survival among patients who crossed over to receive tovecimig.

“While this is not the response we expected, we respect the FDA’s feedback and our priority is to work with the agency to determine the best path forward to support our planned BLA submission and address this pressing unmet need,” says Compass CEO Thomas Schuetz.

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