Biologics

FDA Expands Indication for Anktiva in Bladder Cancer

FDA has approved Altor BioScience’s Anktiva (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The approval revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors to include patients with high-grade papillary-only tumors, according to an agency release.

“The current approval expands the indication to include patients with BCG-unresponsive high-grade NMIBC with papillary-only tumors based on review of available scientific information,” the agency says. “While high-grade papillary and CIS tumors have different architectural growth features, both are considered aggressive urothelial carcinomas, frequently coexist, can be difficult to distinguish pathologically, and, in the BCG-unresponsive setting, are associated with high risk for tumor recurrence and progression. Based on the overlapping clinical and non-clinical features of these two histologic types, the FDA concluded that the prior demonstration of efficacy in patients with BCG-unresponsive NMIBC containing CIS could be extrapolated to patients with BCG-unresponsive high-grade papillary disease.”

Additionally, FDA noted that it is working to finalize it guidance “Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment”' to address the approach on which this approval relied.

Container Closure System Guidance Comments

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s attention to container closure systems in light of the significant technological advances that have emerged in material science and drug delivery systems since the agency’s 1999 guidance on the same topic. In a comment letter on an

Gottlieb Urges FDA Regulatory Pathway for ‘Clinical AI’

Former FDA commissioner Scott Gottlieb is calling on Congress to establish a new regulatory pathway for clinical artificial intelligence models developed and used within hospitals, warning that the absence of consistent federal oversight could undermine patient safety and limit broader commercialization of clinical AI technologies. In an October 8 commentary

FDA Launches Rare Disease Framework Initiative

FDA says it is launching a Rare Disease Framework Initiative “to reimagine the development of drugs and biologics for rare diseases.” In a statement, which includes a link to a new white paper on the initiative, the program will “develop an optimized, fit-for-purpose framework that reflects the realities

Bioresearch Monitoring Issue at Lovelace Institute

A 4/7-4/18/2025 FDA Bioresearch Monitoring Program inspection at Lovelace Biomedical Research Institute in Albuquerque, NM, found objectionable conditions in the facility’s role in conducting two nonclinical laboratory studies. A 10/6 Warning Letter says the specific violation was: * failure of the quality assurance unit to

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Container Closure System Guidance Comments

Gottlieb Urges FDA Regulatory Pathway for ‘Clinical AI’

FDA Launches Rare Disease Framework Initiative

Bioresearch Monitoring Issue at Lovelace Institute