In this article
FDA Approval of Libtayo for Advanced Basal Cell Carcinoma
August 20, 2021: The FDA has given cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) regular approval for patients with locally advanced basal cell carcinoma (laBCC) who have previously been treated with a hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate, as well as accelerated approval for patients with metastatic BCC (mBCC) who have previously been treated with an HH.
Patients with advanced BCC (laBCC or mBCC) who had progressed on HHI therapy, had not had an objective response after 9 months on HHI therapy, or were intolerant to prior HHI therapy were investigated in Study 1620 (NCT03132636), an ongoing open-label, multi-center, non-randomized experiment. A multidisciplinary examination determined that laBCC patients were not candidates for curative surgery or curative RT. Cemiplimab-rwlc 350 mg was given to all patients every 3 weeks for up to 93 weeks, or until disease progression, intolerable toxicity, or the end of the treatment regimen.
Study 1620 Results: Efficacy in laBCC and mBCC
Confirmed objective response rate (ORR) and duration of response (DOR) were the primary efficacy outcome measures, as determined by an independent central review. Confirmed ORR was determined using RECIST 1.1 for patients with no externally evident target lesions (mBCC). For individuals with externally visible target lesions, a composite response assessment comprising clinical response criteria utilising digital medical photography and RECIST 1.1 was used (laBCC and mBCC).
The confirmed ORR was 29% (95 percent CI: 19, 40) among 84 patients with laBCC, with a median DOR of not attained (range: 2.1 to 21.4+ months) and 79 percent of responders continuing their response for at least 6 months. The verified ORR was 21% (95 percent CI: 8, 41) among 28 patients with mBCC, with a median DOR of not attained (range: 9 to 23.0+ months) and all responders maintained their responses for at least 6 months.
Safety Profile and Recommended Dosage
Immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and infusion reactions are examples of severe adverse reactions. Fatigue, musculoskeletal pain, diarrhoea, rash, and pruritis were the most prevalent side effects (incidence 20%).
Cemiplimab-rwlc is given as a 350 mg intravenous infusion over 30 minutes every three weeks until disease progression or intolerable toxicity occurs.
Reference :
Check details .
Take second opinion on basal cell carcinoma
How CancerFax Helps
CancerFax is a specialist cancer access and patient-navigation platform. We help patients and families understand their options, organise medical records, coordinate hospital communication, and support cross-border treatment planning where appropriate.
We help collect and organise reports, scans, pathology, biomarker results, and treatment history for structured case review.
We communicate with hospitals or trial teams to assess whether a case may be suitable for further screening.
We support appointment coordination, document submission, translation, and direct communication with international departments.
For international patients, we help with practical coordination — travel planning, hospital admission guidance, and local support.
If this option is not suitable, we help explore other relevant treatments, clinical trials, or advanced care pathways.
From inquiry through to follow-up, our coordinators provide a single point of contact for the family.
CancerFax does not guarantee treatment access, eligibility, or clinical outcome. Our role is to help patients access accurate information, structured review, and appropriate specialist pathways.
Related Articles
About Susan Hau
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy. Hau's expertise lies in cancer cell biolo…
✓ Reviewed for medical accuracy by the CancerFax review panel.
Medical Disclaimer
This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
Treatment availability, eligibility, timelines, and access can change. Any clinical trial participation depends on detailed review and approval by the trial hospital or investigator.