The Pharmaceutical Administration Bureau (ISAF) of Macau SAR, China, granted regulatory approval for ANKTIVA® (nogapendekin alfa inbakicept-pmln) in combination with BCG for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. This represents the therapy’s first regulatory authorization in Asia.
Indication and Treatment Context
In Macau, ANKTIVA is approved for use in combination with intravesical BCG. Patients with BCG-unresponsive NMIBC with CIS ± papillary disease constitute a particularly challenging clinical population, as therapeutic options that preserve the bladder are limited once standard BCG therapy fails.
NMIBC accounts for the majority of newly diagnosed bladder cancer cases, and CIS is associated with a substantial risk of progression to muscle-invasive disease.
Radical cystectomy is frequently recommended in the BCG-unresponsive setting; however, many patients are either medically unfit for surgery or reluctant to undergo a procedure with significant functional and quality-of-life implications.
Consequently, treatments capable of achieving durable disease control while avoiding cystectomy remain an important unmet need.
Reliance-Based Regulatory Pathway
The Macau authorization was granted through a reliance-based review process. Under this framework, local regulators consider prior assessments conducted by established agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), in addition to jurisdiction-specific requirements.
Reliance pathways are increasingly adopted by smaller regulatory authorities to expedite access to innovative therapies that have already undergone rigorous evaluation elsewhere, while preserving independent decision-making and oversight.
Mechanism of Action
ANKTIVA is a first-in-class interleukin-15 (IL-15) receptor agonist designed to enhance immune responses against cancer. In contrast to immune checkpoint inhibitors, which primarily remove inhibitory signals from T cells, IL-15–based therapies aim to actively stimulate expansion and activation of cytotoxic immune populations.
Available data indicate that ANKTIVA promotes the proliferation and activation of natural killer cells, CD8-positive cytotoxic T lymphocytes, and long-lived memory immune cells. By engaging both innate and adaptive immunity, the therapy is intended to strengthen antitumor activity within the bladder microenvironment when administered alongside BCG.
Clinical Evidence
The approval references findings from the QUILT-3.032 clinical trial, which evaluated ANKTIVA in patients with BCG-unresponsive NMIBC with CIS with or without papillary tumors. Reported outcomes include a complete response rate of 71 percent and a median duration of response of 26.6 months.
These results have been published in peer-reviewed journals, including NEJM Evidence and The Journal of Urology. Durable responses are particularly meaningful in this disease setting, where recurrence is common and long-term bladder preservation is a central therapeutic objective.
Regional and Global Implications
Although Macau’s population is relatively small, the approval carries broader significance beyond the territory itself. It represents the first authorization of ANKTIVA in Asia and may serve as a strategic entry point into the wider Asia-Pacific regulatory environment.
The decision also reflects the expanding role of reliance-based regulatory mechanisms in facilitating earlier patient access to innovative oncology therapies.
Comment from Dr. Patrick Soon-Shiong
Dr. Patrick Soon-Shiong, founder and Executive Chairman of ImmunityBio, also commented on the announcement in a post on X, highlighting the broader significance of the approval.
“Global expansion-first approval in Asia!! Anktiva now approved in Macau, China today. Paradigm change of treating the immune system unstoppable.”
Looking Ahead
While the authorization in Macau expands geographic access to ANKTIVA, its real-world impact will depend on several factors, including clinical adoption, reimbursement policies, manufacturing capacity, and outcomes observed in routine practice.
For patients with BCG-unresponsive NMIBC seeking bladder-preserving alternatives, this approval introduces an additional therapeutic option.
Ongoing regulatory reviews and post-authorization experience will determine the extent to which this approach becomes integrated into clinical care across Asia and globally.
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Written by Nare Hovhannisyan,MD