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The approval is supported by results from the phase 3 NIAGARA trial.

"The striking CR rates observed in these early cohorts are highly encouraging, particularly for BCG-unresponsive NMIBC patients who currently have limited treatment options," says Paul D. Anderson, MBBS, FRACS.

"Provided that we will confirm the efficacy data long-term, there is an opportunity to spare, de-escalate a bit, the treatment in select patients, and to expose the patient with inferior risk of developing severe [adverse] effects," says Andrea Necchi, MD.

In patients with intermediate-risk disease, 4 of 5 patients demonstrated a complete response.

"Now with the new translational data indicating that post-treatment close contact precautions are unnecessary, I am confident that cretostimogene will represent a breakthrough in bladder cancer treatment, if approved by the FDA," says Trinity J. Bivalacqua, MD, PhD.

“The addition of the durvalumab did not make treatment more morbid than chemotherapy alone, and it didn't change or increase the surgical complications you saw in the ward," says James W.F. Catto, MBChB, PhD, FRCS.

"The implication for real-world decision-making is that this drug appears to hold up to what was seen in the trial," says Mark D. Tyson II, MD, MPH.

"These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence," says Stephen B. Williams, MD, MBA, MS, FACS, FACHE.

"Ultimately, there is no 'right choice' when it comes to urinary diversion," writes Anne K. Schuckman, MD.

There are also 60 sites in the process of launching the EAP.

The pCR rate was 33% with APL-1202 plus tislelizumab compared with 26% with tislelizumab alone.

According to ImmunityBio, shipments of rBCG are set to begin immediately via the EAP.

“Among active surveillance patients, 82% are metastases-free, and 60% were metastases-free and had an intact, unradiated bladder,” said Pooja Ghatalia, MD.

Anktiva is also currently under review for the CIS indication in the EU.

"The results [indicate] that neoadjuvant DV combined with toripalimab had promising efficacy and acceptable safety in patients with HER2-expressing MIBC,” said Xinan Sheng, MD.

The pCR was 37.3% (95% CI, 33.2-41.6) in the durvalumab arm and 27.5% (95% CI, 23.8-31.6) in the comparator arm.

OS was found to be prolonged with avelumab plus BSC vs BSC alone regardless of diabetes mellitus status.

The investigators reported that there were 24 evaluable patients with CIS with/without papillary disease, of whom 79% had a CR at 3 months.

The median duration of response was 47.8 months among patients who achieved an initial complete response.

"One way to think about how Anktiva works is it is the first molecule, based on the package insert, that increases and proliferates the NK cells, the T cells, and the CD4+ and CD8+ T cells, without up-regulating the suppressive T cells," says Patrick Soon-Shiong, MD.

In total, 28% of patients with luminal tumors and 41% of patients with nonluminal tumors experienced upstaging to nonorgan confined disease.

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If approved, the marketing authorization application would be valid in all 27 European Union member states as well as in Iceland, Liechtenstein, and Norway.

"The three-year durability data from this study further validate the potential of JELMYTO in providing long-term disease control for patients with low-grade upper tract urothelial cancer,” says Solomon L. Woldu, MD.

The accuracy of PLND was 93.41% in the ICG injection arm compared with 75.91% in the control arm.

“If patients are not experiencing a clear clinical benefit for chemotherapy prior to surgery, we need to be really thoughtful about how we use it,” says Fed Ghali, MD.

The planned sBLA will seek approval of Anktiva for patients with BCG-unresponsive NMIBC in the papillary indication.

The NDA is supported by data from cohort 2 of the phase 2b SunRISe-1 trial.