Onco-Summaries: Daily Oncology Updates at a Glance
14/10/2026
ImmunityBio secures US FDA expansion for ANKTIVA in BCG-Unresponsive Papillary Bladder Cancer (Ref)
The US FDA expanded the approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln; IL-15 receptor agonist) in combination with BCG to include patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with papillary disease, in addition to the previously approved CIS population. The expanded label now covers both papillary and CIS disease, broadening the eligible patient population
The approval makes ANKTIVA + BCG the first FDA-approved therapy indicated across both CIS and papillary forms of BCG-unresponsive NMIBC.
The expansion is supported by data from the QUILT-3.032 study, which demonstrated durable responses in patients with BCG-unresponsive disease.
In the CIS cohort, the study reported a 62% complete response rate, with a substantial proportion of responders maintaining response for at least 12 and 24 months.
The safety profile remained consistent with previous experience, with most adverse events being low grade and primarily urinary/bladder related
Tab-cel BLA resubmission accepted by US FDA for EBV+ PTLD; PDUFA date set for March 2027 (Ref)
Atara Biotherapeutics announced that the US FDA has accepted the resubmitted Biologics License Application (BLA) for tabelecleucel (tab-cel®; allogeneic, Epstein-Barr virus (EBV)-specific T-cell immunotherapy), advancing the regulatory review of the therapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD)
The FDA assigned a March 31, 2027 PDUFA target action date and classified the submission as a Class 2 resubmission
The BLA seeks approval of tab-cel for adults and pediatric patients aged 2 years and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy
If approved, tab-cel would become the first approved treatment in the United States for EBV+ PTLD, a rare and life-threatening post-transplant complication
Tab-cel has previously received Breakthrough Therapy and Orphan Drug designations from the FDA
Comments