Top Stories
CHMP Backs Amgen's Imdelltra for EU Approval in Small Cell Lung Cancer
The EMA's Committee for Medicinal Products for Human Use recommended approval of Amgen's Imdelltra (tarlatamab) as a second-line treatment for extensive-stage small cell lung cancer on March 30, 2026, according to Pharmaphorum. The recommendation is based on the phase III DeLLphi-304 study, which reported a 40% reduction in the risk of death and more than five months' improvement in median overall survival compared to standard second-line chemotherapy. Imdelltra is a bispecific T-cell engager (BiTE) that targets DLL3, a protein present on the majority of SCLC tumours with limited expression on healthy tissue. The CHMP opinion follows US FDA full approval granted in November 2025 and UK approval. If endorsed by the European Commission, Imdelltra would become the first DLL3-targeted therapy available across all major markets. ES-SCLC patients in the EU gain access to a targeted immunotherapy option Standard second-line chemotherapy regimens face displacement
Darzalex Becomes First Oncology Injectable Approved for Patient Self-Administration in EU
The EMA's CHMP approved a label update for Johnson & Johnson's Darzalex (daratumumab) subcutaneous formulation on March 27, 2026, making it the first oncology injectable approved in Europe for self-administration by patients or caregivers, as reported by Pharmaceutical Technology and PharmaTimes. The update enables patients with multiple myeloma to self-administer from the fifth dose onward, following healthcare provider assessment and training. The label change applies across all ten therapeutic indications for daratumumab SC, including multiple myeloma, smouldering multiple myeloma, and light chain amyloidosis. Daratumumab SC is co-formulated with Halozyme's Enhanze rHuPH20 drug delivery technology and was first approved in the EU in 2020. Myeloma patients gain home-administration flexibility Infusion centre visit volumes may decline for maintenance doses
FDA Grants Priority Review to Lirafugratinib for Cholangiocarcinoma
The FDA accepted the NDA for lirafugratinib in FGFR2-altered cholangiocarcinoma and granted priority review with a September 27, 2026 PDUFA date, according to Targeted Oncology. This FGFR inhibitor represents a potentially significant advance for cholangiocarcinoma patients who have limited treatment options beyond standard chemotherapy. The priority review designation indicates FDA recognizes lirafugratinib could provide substantial improvement over existing therapies for this aggressive bile duct cancer. FGFR2 alterations are estimated to occur in approximately 10-15% of intrahepatic cholangiocarcinoma patients according to published literature, creating a defined biomarker-driven opportunity. The accelerated six-month review timeline positions lirafugratinib for potential approval before year-end 2026, giving it first-mover advantage in the FGFR2-positive cholangiocarcinoma space. FGFR2-positive cholangiocarcinoma patients gain targeted therapy option Competing FGFR inhibitors face higher regulatory bar
Pipeline Watch
The FDA granted fast track designation to a folate receptor alpha-targeting antibody-drug conjugate for ovarian cancer treatment, according to Targeted Oncology. FRα represents an attractive target expressed on most ovarian cancers with limited normal tissue expression, potentially enabling improved therapeutic windows compared to existing ADCs.
The FDA approved Pylarify TruVu for PSMA-PET imaging in prostate cancer patients, according to OncLive. This approval adds another option to the growing PSMA-PET landscape, providing urologists and oncologists with additional flexibility in prostate cancer staging and recurrence detection workflows.
Competitive Landscape
Lirafugratinib priority review positions it ahead of competing FGFR inhibitors in cholangiocarcinoma, per Targeted Oncology. The September PDUFA date creates first-mover advantage in the FGFR2-altered subset representing 10-15% of patients.
| Asset | Indication | Timeline |
|---|---|---|
| Lirafugratinib | FGFR2+ CCA | PDUFA Sep 2026 |
| Competing FGFR | Broader CCA | Phase II ongoing |
| Standard Chemo | All CCA | Current SOC |
FRα-targeting ADCs gain FDA fast track designation in ovarian cancer, broadening the ADC competitive landscape beyond HER2 and Trop-2 targets, according to Targeted Oncology. This validates folate receptor as a viable ADC target for solid tumors.
Amgen's Imdelltra (tarlatamab) CHMP recommendation positions the BiTE therapy as a potential new standard of care in second-line ES-SCLC across the EU, per Pharmaphorum. With a 40% reduction in death risk shown in DeLLphi-304, competing second-line chemotherapy regimens face direct challenge.
| Asset | Mechanism | Status |
|---|---|---|
| Imdelltra (tarlatamab) | DLL3-targeting BiTE | CHMP Positive Opinion |
| Standard Chemotherapy | Topotecan/Lurbinectedin | Current 2L SOC |
J&J's Darzalex label update enabling patient/caregiver self-administration could pressure competing subcutaneous oncology injectables to pursue similar label expansions, as reported by Pharmaceutical Technology. The move strengthens Darzalex's competitive moat in the multiple myeloma market by improving patient convenience.
Forward Looking
- Lirafugratinib September 27 PDUFA date will determine first FGFR2-targeted approval in cholangiocarcinoma and set competitive benchmark for class
- FRα-targeting ADC fast track designation signals FDA openness to novel ADC targets beyond established HER2 and Trop-2 platforms
- European Commission decision on Imdelltra expected in coming months; if approved, Amgen gains first DLL3-targeted therapy across all major markets for ES-SCLC
- Darzalex self-administration precedent may accelerate label expansion efforts for other subcutaneous oncology injectables in the EU