Drugs

Compass Therapeutics Reports on Tovecimig Trial Data

Compass Therapeutics is announcing statistically significant top-line data on the primary efficacy endpoint from its COMPANION-002 trial, an ongoing Phase 2/3 randomized study of tovecimig in combination with paclitaxel in patients with advanced biliary tract cancer. The trial evaluated tovecimig in 168 patients with unresectable advanced, metastatic or recurrent biliary tract cancers who have received one prior systemic chemotherapy regimen.

The company says 17.1% of patients treated with tovecimig in combination with paclitaxel (19 of 111 patients) had an objective response rate, including one complete response, compared to 5.3% for patients treated with paclitaxel alone (3 of 57 patients). Regarding secondary endpoints (progression-free survival, overall survival, and duration of response), it says data are not yet mature for these analyses. “The trial requires a threshold of events in 80% of patients to trigger the secondary endpoint analyses,” it says, adding that these should be reported in the fourth quarter.

Regarding safety, Compass says tovecimig’s safety profile is consistent with prior studies involving the therapy.

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

Read more

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