Drugs

ALX Oncology Seeking Accelerated OK for Evorpacept

ALX Oncology says it plans to discuss with FDA its path for seeking accelerated approval for its investigational CD47-blocker evorpacept based on “positive updated data” from the ASPEN-06 Phase 2 clinical trial demonstrating the therapy generates a durable clinical response with a well-tolerated safety profile among patients with previously treated HER2-positive advanced gastric cancer or gastroesophageal junction (GEJ) cancer. “The updated data from the ASPEN-06 trial highlight the potential clinical utility of CD47 inhibition from evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with previously treated HER2-positive gastric cancer,” a company release says.

ASPEN-06 is a randomized international trial (NCT05002127) evaluating evorpacept in combination with trastuzumab, ramucirumab and paclitaxel (collectively, ETRP) against trastuzumab, ramucirumab and paclitaxel in patients with HER2-positive gastric/GEJ cancer. The updated data show ETRP demonstrated an “objective response rate of 41.3% compared to 30%” for the control population, the company says.

“The results from this trial tell a clear story that when a cancer cell is expressing HER2, evorpacept can combine with a regimen containing an anti-HER2 antibody such as trastuzumab to improve upon the activity you would expect from that regimen alone,” ALX Oncology says. “This is evidenced by the near doubling of PFS [progression-free survival] at one year among the patients with HER2-positivity….”

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