ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

Shots:The UK’s MHRA has approved Anktiva + Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive NMIBC with CIS. MAA is under the EMA’s review & covers all 30 EEA statesApproval was based on safety & efficacy data, incl. CR & DoR, from a single-arm trial in 77 pts treated with Anktiva + BCG, with some…

ByRidhi RastogiJuly 8, 2025

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UroGen Pharma Receives the US FDA’s Approval for Zusduri to Treat LG-IR-NMIBC

Shots:The US FDA has approved Zusduri (mitomycin) for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC); expected to be available in the US by Jul 1, 2025Approval was based on P-III (ENVISION) trial assessing Zusduri (QW, intravesical) in ~240 LG-IR-NMIBC pts across 56 sites, which showed 78% pts…

ByRidhi RastogiJune 13, 2025

NEWS

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024 The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…

ByDipanshu DixitApril 22, 2024

ImmunityBio’s Anktiva + BCG Receives the MHRA’s Approval for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ

UroGen Pharma Receives the US FDA’s Approval for Zusduri to Treat LG-IR-NMIBC

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

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