Biologics

FDA Rejects Y-mAbs BLA for Brain Condition

FDA has issued Y-mAbs Therapeutics a complete response letter on its BLA for I-omburtamab and its use in treating CNS/leptomeningeal metastasis from neuroblastoma, a serious condition in which cancer cells spread from the original tumor to the meninges (the thin layers of tissue that cover and protect the brain and spinal cord). The letter recommends a meeting with the agency to discuss an adequate and well-controlled trial design to demonstrate substantial evidence of effectiveness and a favorable benefit-risk profile.

In late October, FDA’s Oncologic Drugs Advisory Committee voted 16 to 0 that Y-mAbs Therapeutics’ BLA did not provide sufficient evidence to conclude that omburtamab improves overall survival. FDA medical reviewers told the panel they were unable to establish a substantive risk/benefit relationship for using I-omburtamab. In a briefing paper, the reviewers identified these issues with the application:

the external control population is not fit-for-purpose as a comparator due to substantive differences between the study and control populations that limit the ability to attribute survival differences to the effect of the drug;
recognizing the level of evidence provided and the need for regulatory flexibility, FDA performed additional analyses to examine bias and those results reinforced that differences in survival cannot be reliably attributed to I-omburtamab; and
the application did not include reliable response rate data to provide supportive evidence of the drug’s treatment effect.

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