Shots:
The EC has granted conditional approval to Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS, & with/without papillary tumors in all 30 EEA states, based on P-II/III (QUILT-3.032) study (n=100)
Trial showed a 71% CR rate, with a median duration of CR of 26.6mos., plus DoR range was as long as…
Shots:
The EMA has recommended conditional EU marketing authorization for Anktiva (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC carcinoma in situ. Â
Recommendation was based on safety and efficacy data in 100 adults, showing a 71% CR rate, with responses lasting a median of ~27 mos and extending up to 54+ mos; CR rates among responders were 66% at…

