Basal cell carcinoma is a skin cancer arising from basal cells in the epidermis. It usually grows slowly and rarely metastasizes, but can become locally destructive if not treated early.
FDA clears SkinStylus for periorbital wrinkles across all skin types; accepts Biofrontera's sNDA for Ameluz PDT in superficial BCC with a September 2026 PDUFA date; Belite Bio completes rolling NDA submission for tinlarebant in Stargardt disease.
The FDA has cleared an IND for Amphista's novel BRD9 degrader AMX-883 for AML, approved Lantheus' new prostate cancer imaging agent Pylarify TruVu, and accepted Biofrontera's sNDA for Ameluz PDT in superficial basal cell carcinoma. These regulatory milestones span hematologic and solid tumor areas, addressing significant unmet medical needs.
The FDA has accepted a supplemental new drug application for aminolevulinic acid hydrochloride plus red light therapy for superficial basal cell carcinoma, with a decision date set for September 28, 2026.
Secondary analysis of KEYNOTE-716 trial finds adjuvant pembrolizumab improves recurrence-free survival in stage IIB/IIC melanoma without increasing new primary melanoma risk, while reducing non-melanoma skin cancers.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07571031 |
Inter-Operator Variability in the Clinical Staging and Therapeutic Management of Basal Cell Carcinoma |
NOT_YET_RECRUITING | |
| NCT07482956 |
BCC-One-Stop-Study |
NOT_YET_RECRUITING | NA |
| NCT07285044 |
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas |
RECRUITING | PHASE2 |
| NCT07241585 |
Vitamin D Effects on Immune Microenvironment of Nonmelanoma Skin Cancer After Photodynamic Therapy (PDT) |
NOT_YET_RECRUITING | NA |
| NCT07182240 |
Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas |
RECRUITING | NA |
| NCT06624475 |
Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma |
RECRUITING | PHASE2 |
| NCT06600165 |
Intraoperative Confocal Laser Scanning Microscopy With Use of AI for Optimized Surgical Excision of Basal Cell Carcinoma |
RECRUITING | |
| NCT06598137 |
Study to Examine Lesions of the Skin Using Confocal Laser Microscopy |
ACTIVE_NOT_RECRUITING | |
| NCT06536257 |
Personalised Immunotherapy Platform |
RECRUITING | |
| NCT06473103 |
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy |
RECRUITING | NA |
