FDA approves first gene therapy for high-risk, non-muscle-invasive bladder cancer

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Earlier this year, FDA announced that it would be initiating a voucher program aimed at accelerating review time for applications that are deemed to be advancing U.S. “national priorities” (The Cancer Letter, June 20, 2025).

October 24, 2025

Vol.51 No.39

By Claire Marie Porter

Clinical Roundup

Keytruda + Padcev reduced risk of EFS events and death for muscle-invasive bladder cancer when given before and after surgery

Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) reduced the risk of event-free survival events by 60% and reduced the risk of death by 50% when given before and after surgery (radical cystectomy) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer who are not eligible for or declined cisplatin-based chemotherapy, according to phase III KEYNOTE-905/EV-303 trial data.

October 24, 2025

Vol.51 No.39

Clinical Roundup

Imfinzi regimen reduced the risk of disease recurrence or death by 32% in high-risk non-muscle-invasive bladder cancer

Positive results from the POTOMAC phase III trial showed adding one year of treatment with Imfinzi (durvalumab) to BCG induction and maintenance therapy demonstrated a statistically significant and clinically meaningful improvement in disease-free survival for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer compared to BCG treatment alone.

October 24, 2025

Vol.51 No.39

Clinical Regulatory News Trials & Tribulations

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL).

October 17, 2025

Vol.51 No.38

By Edison T. Liu

News Analysis Regulatory News

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

Bowing to the growing animal rights movement, FDA and NIH have made policy changes to discourage animal testing, instead favoring alternative research models.

October 17, 2025

Vol.51 No.38

By Claire Marie Porter and Jacquelyn Cobb

Drugs & Targets

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

FDA has received reports of immune effector cell-associated enterocolitis in patients who received treatment with Carvykti.

October 17, 2025

Vol.51 No.38

FDA approves first gene therapy for high-risk, non-muscle-invasive bladder cancer

YOU MAY BE INTERESTED IN

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Keytruda + Padcev reduced risk of EFS events and death for muscle-invasive bladder cancer when given before and after surgery

Imfinzi regimen reduced the risk of disease recurrence or death by 32% in high-risk non-muscle-invasive bladder cancer

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

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FDA approves first gene therapy for high-risk, non-muscle-invasive bladder cancer

YOU MAY BE INTERESTED IN

Revolution Medicines’ pancreatic cancer drug received a new priority voucher from FDA

Keytruda + Padcev reduced risk of EFS events and death for muscle-invasive bladder cancer when given before and after surgery

Imfinzi regimen reduced the risk of disease recurrence or death by 32% in high-risk non-muscle-invasive bladder cancer

Under the lens: Taking a close look at the NIH and FDA declarations on animal-based research

How animal testing became a MAHA political wedge issueWhile cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough

FDA requires a boxed warning for immune effector cell-associated enterocolitis following Carvykti treatment

Never miss an issue!

Login

How animal testing became a MAHA political wedge issue
While cancer scientists say NIH, FDA moves are premature, animal rights advocates say changes aren’t drastic enough