Onco-Summaries: Daily Oncology Updates at a Glance

28/04/2026

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• FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027

  
  

• FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies

  
  

• Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma

  
  

• Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint

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FDA accepts NDA for zipalertinib in EGFR exon 20–mutated NSCLC; PDUFA set for Feb 2027 (Ref)

The US FDA has accepted the New Drug Application (NDA) for Taiho & Cullinan Therapeutics' zipalertinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, in patients whose disease progressed after platinum-based chemotherapy, with or without amivantamab

• The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027

The NDA is supported by data from the Phase 2b part of the REZILIENT1 clinical trial of zipalertinib monotherapy in patients with NSCLC harboring EGFR ex20ins mutations who have received prior therapy

• The confirmed objective response rate (ORR) was 35%. Median duration of response (mDOR) was 8.8 months

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FDA Grants RMAT Designation to Orca-Q, Advancing Precision Cell Therapy for High-Risk Hematologic Malignancies (Ref)

Orca-Q®, Orca Bio’s second-generation investigational allogeneic T-cell immunotherapy, has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA for treating high-risk hematologic malignancies

The RMAT status was based on promising preliminary Phase 1 clinical data showing positive outcomes in overall survival, reduced acute and chronic graft-versus-host disease (GVHD), and lower non-relapse mortality

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Scancell’s iSCIB1+ secures FDA Fast Track with 77% PFS, Phase 3 initiation anticipated in H2 2026 for advanced Melanoma (Ref)

Scancell’s lead ImmunoBody® candidate, iSCIB1+, received Fast Track status for advanced melanoma

• In Phase 2 SCOPE trial 77% progression-free survival (PFS) observed at 20 months when combined with ipilimumab and nivolumab

Next steps: Initiation of the registrational Phase 3 trial with iSCIB1+ in advanced melanoma anticipated in H2 2026

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Henlius secures EU approval for POHERDY® (pertuzumab biosimilar), expanding global oncology footprint (Ref)

The European Commission approved HLX11 (pertuzumab, branded as POHERDY®) for HER2‑positive early and metastatic breast cancer

Indications:

• Neoadjuvant/adjuvant use with trastuzumab + chemotherapy in high‑risk HER2‑positive early breast cancer

• Combination with trastuzumab + docetaxel in HER2‑positive metastatic or locally recurrent unresectable breast cancer (first‑line)

Basis of Approval: HLX11 demonstrated analytical, PK, and clinical similarity to the reference drug PERJETA®. EU GMP certification (Belgium, 2025) and a positive CHMP opinion (Feb 2026) supported the decision

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