Onco-Summaries: Daily Oncology Updates at a Glance

18/02/2026

---

• ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS

  
  

• Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN

---

ImmunityBio's ANKTIVA® + BCG received conditional marketing authorization in Europe for BCG-unresponsive NMIBC CIS (Ref)

The EC granted conditional marketing authorization to ImmunityBio's ANKTIVA® (nogapendekin alfa inbakicept) + Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive NMIBC CIS, with or without papillary tumors.

• ANKTIVA + BCG is the first authorized treatment in Europe for BCG-unresponsive NMIBC CIS

• The conditional marketing authorization follows the positive opinion adopted by the CHMP, and is based on results from the Ph2/3 QUILT-3.032 study (NCT03022825)

Johnson & Johnson's subcutaneous amivantamab received the FDA Breakthrough Therapy Designation for HPV-unrelated R/M SCCHN (Ref)

The US FDA granted the Breakthrough Therapy Designation to Johnson & Johnson's subcutaneous amivantamab and hyaluronidase-lpuj as a monotherapy for the treatment of adults with HPV-unrelated R/M SCCHN after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

• The BTD is supported by data from the open‑label Phase 1b/2 OrigAMI‑4 study

• Based on these findings, subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study (NCT07276399), which is assessing the subcutaneous amivantamab + pembrolizumab + carboplatin vs pembrolizumab + platinum-based chemotherapy + 5FU as a first-line treatment in patients with HPV-unrelated R/M SCCHN, regardless of PD-L1 expression