Biologics

ImmunityBio sBLA Filing Refused on Expanded Indication

FDA has issued ImmunityBio a refusal to file letter for its recent supplemental BLA submission seeking approval for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guerin (BCG) for treating papillary disease in non-muscle invasive bladder cancer (NMIBC) patients. Papillary diseases are characterized by tumors with a papillary growth pattern (finger-like projections from a surface).

Anktiva was approved last year for use with BCG for treating NMIBC with papillary tumors with carcinoma in situ (CIS) with or without Ta or T1 disease. Ta refers to a tumor confined to the innermost layer of the bladder lining, and T1 refers to a tumor that has invaded the connective tissue beneath the bladder lining but not yet the muscle layer.

FDA’s latest letter may suggest a different review perspective under the new Trump administration. The company says it was received “despite reaching unanimous guidance and encouragement at the in-person 1/2025 meeting from the leadership of the agency, including from CBER, CDER and OCE [Oncology Center of Excellence] to submit this sBLA… Relying on this unanimous guidance the company submitted the sBLA in 3/2025. The company has already requested an urgent meeting to resolve the inconsistencies between the directives provided at the January Meeting and receipt of the RTF letter.”

“The agency must explain the confounding inconsistency of approving Anktiva+BCG for patients with papillary with CIS disease, while refusing to file the sBLA for patients with papillary without CIS disease — even though both groups were part of the same trial, in the same high-risk population of BCG-unresponsive non-muscle invasive bladder cancer,” ImmunityBio says.

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