Drugs

FDA Partial Hold Lifted on Northwest Bio GBM Therapy

FDA has lifted a partial clinical hold on a Northwest Biotherapeutics Phase 3 trial of its personalized immune therapy DCVax-L for glioblastoma multiforme brain cancer. The company says that the trial has “accumulated a sufficient number of events toward the progression-free survival (PFS) endpoint, but not yet for the overall survival (OS) endpoint. The company remains blinded to all trial data, and is only receiving and reporting updates on a blinded basis.”

The partial hold was ordered 2015 after FDA requested unspecified clinical trial information. Under the hold, new screening of patient candidates for the trial had been temporarily suspended. “Such screening involves the initial evaluation of patient candidates to determine whether they meet eligibility criteria for the trial (e.g., whether they are within the eligible age range, do not have certain viral diseases, etc.),” the company explained at the time.

Northwest Bio has announced that it will enroll the last 17 of the planned 348 patients. “There are 331 patients enrolled in the trial, is says. The trial endpoints involve thresholds of 248 ‘events’ for PFS and 233 ‘events’ for OS. PFS events are primarily tumor progression (i.e., recurrence), although they can occasionally be patient deaths which occur without prior evidence of tumor recurrence. OS events are patient deaths. The PFS and OS events are continuing to accumulate as the trial continues. The PFS events have surpassed the 248-event threshold, but the OS events have not yet reached the 233-event threshold. Based upon the pace of OS events during the last six to eight months, the company’s current anticipation is that it will be several months until the trial reaches 233 OS events.”

The company says that external parties managing the trial are now moving forward with the process to reach data lock. “In this process, all data from all of the treatment visits and follow up visits for all 331 patients in the trial, must be subjected to quality control checking,” it says. “The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images.”

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