Nogapendekin Alfa Combo Earns UAE Marketing Authorization in NMIBC, NSCLC

The Emirates Drug Establishment (EDE) of the United Arab Emirates (UAE) has granted marketing authorization for nogapendekin alfa inbakicept (Anktiva) across 2 indications: in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), and in combination with immune checkpoint inhibitors for adult patients with metastatic non–small cell lung cancer (NSCLC), according to a news release from the developer, ImmunityBio.¹

The UAE is the fifth regulatory jurisdiction to authorize the agent, extending its global regulatory footprint to 34 countries. The NMIBC authorization is described as the first worldwide to span the full spectrum of BCG-unresponsive disease, including carcinoma in situ (CIS) with or without papillary tumors, and papillary disease alone without CIS.

What does the UAE authorization cover?

Per the approved UAE Summary of Product Characteristics, the 0.4-mg nogapendekin alfa inbakicept solution for intravesical instillation is indicated with BCG for BCG-unresponsive NMIBC with CIS with or without papillary tumors, and for BCG-unresponsive NMIBC with papillary tumors alone. The 1.2-mg nogapendekin alfa inbakicept solution for subcutaneous injection is indicated in combination with immune checkpoint inhibitors for metastatic NSCLC with disease progression on or after standard of care.

In the NSCLC indication, the agent is administered as a fixed 1-mg subcutaneous dose once every 21 days for the duration of checkpoint inhibitor therapy. The EDE issued marketing authorization for both presentations with first registration in July 2026 and validity through July 2031. ImmunityBio is the marketing authorization holder, with Modern Pharmaceutical Company serving as its local agent in the UAE.

What efficacy data support the NMIBC indication?

The NMIBC authorization is supported by the findings from the multicenter registrational phase 2/3 QUILT-3.032 study (NCT03022825). In the CIS cohort (n = 100), nogapendekin alfa inbakicept plus BCG produced a complete response (CR) rate of 71% (95% CI, 61%-80%), with a median duration of CR of 26.6 months (95% CI, 13.0-49.9) among the 71 patients who achieved a response; 66% of responders remained in CR at 12 months and 42% at 24 months.

In the papillary-only cohort (n = 80), the 12-month disease-free survival (DFS) rate was 58.2% (95% CI, 46.6%-68.2%), with a median DFS of 25.3 months (95% CI, 9.8-33.5), and the cystectomy-free rate was 83.1% (95% CI, 70.8%-90.5%) at 36 months. Across the QUILT-3.032 program, most treatment-related adverse effects (TRAEs) were grade 1 or 2; grade 3 events occurred in 1% of patients, with no grade 4 or 5 TRAEs reported.

What efficacy data support the NSCLC indication?

The NSCLC authorization is supported by the phase 3 QUILT-2.023 trial (NCT03520686)findings, in which investigators assessed nogapendekin alfa inbakicept plus a checkpoint inhibitor in patients with advanced NSCLC that had progressed on prior checkpoint inhibitor therapy (n = 79). The median overall survival (OS) was 14.6 months (95% CI, 12.0-19.5); among the 77% of patients who achieved an absolute lymphocyte count of at least 1000 cells/μL on treatment, the median OS was 16.2 months (95% CI, 13.8-22.0), compared with 11.8 months (95% CI, 6.9-14.1) among those who did not reach that threshold (HR, 0.52; 95% CI, 0.28-0.97; log-rank P = .0369).

The most common treatment-related adverse reactions were injection site reactions (86%), chills (46%), fatigue (32%), and pyrexia (28%).

“This approval in [patients with] lung cancer who [progressed on] checkpoint inhibitors supports the evidence that the MHC-I receptor is lost in patients who progressed on checkpoint inhibitors," Patrick Soon-Shiong, MD, founder, executive chairman, and global chief medical and scientific officer of ImmunityBio, stated in the press release.¹

What is the regulatory status of nogapendekin alfa inbakicept elsewhere?

Nogapendekin alfa inbakicept plus BCG is also authorized for BCG-unresponsive NMIBC with CIS in the US, UK, EU, and Saudi Arabia, while the NSCLC indication has previously been authorized only in Saudi Arabia, where the Saudi Food and Drug Authority granted accelerated approval in January 2026, marking the first global approval of the combination in that setting.^2,3 In the US, a supplemental biologics license application covering the papillary-only NMIBC population was accepted by the FDA in May 2026, with a Prescription Drug User Fee Act target action date of January 6, 2027; nogapendekin alfa inbakicept has not been approved for NSCLC in the US.⁴

"Securing approvals across 2 distinct indications, bladder cancer and lung cancer, on the strength of the same data packages we submitted to the FDA, positions us to broaden access across the Gulf region through our partnership with Modern Pharmaceutical Company, in markets where the need for new treatment options is significant," Richard Adcock, president and chief executive officer of ImmunityBio, stated in the press release.¹

References

1. ImmunityBio receives United Arab Emirates (UAE) marketing authorization for Anktiva across BCG-unresponsive non-muscle invasive bladder cancer for CIS and papillary disease and metastatic non-small cell lung cancer. News release. ImmunityBio, Inc. July 29, 2026. Accessed July 29, 2026. https://tinyurl.com/mwtkfsvx
2. Saudi FDA grants accelerated approval to ImmunityBio's Anktiva in combination with checkpoint inhibitors for metastatic non-small cell lung cancer. News release. ImmunityBio, Inc. January 14, 2026. Accessed July 29, 2026. https://tinyurl.com/42xnz7wm
3. Saudi FDA grants accelerated approval to ImmunityBio’s Anktiva for non-muscle invasive bladder cancer with carcinoma in-situ. News release. ImmunityBio, Inc. January 14, 2026. Accessed July 29, 2026. https://tinyurl.com/4jaehcsf
4. ImmunityBio announces FDA acceptance of supplemental BLA for ANKTIVA® plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease; PDUFA date set for January 6, 2027. News release. ImmunityBio, Inc. May 19, 2026. Accessed July 29, 2026. https://tinyurl.com/359e8jwc