Cemiplimab-rwlc has been approved by the FDA for the treatment of locally progressed and metastatic basal cell carcinoma

Share This Post

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.

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.

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 : https://www.fda.gov/

 

Check details here.

Take second opinion on basal cell carcinoma


Send Details

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient A case report
CAR T-Cell therapy

Claudin18.2-targeted CAR-T cell therapy brings complete remission in advanced pancreatic cancer patient : A case report

Claudin18.2-targeted CAR-T cell therapy has shown remarkable potential in treating advanced pancreatic cancer, as highlighted in a recent case report. This innovative approach led to complete remission in a patient with advanced disease, underscoring the promise of targeted immunotherapy. By leveraging the specific expression of Claudin18.2 on cancer cells, this therapy offers a precision-based treatment, heralding a new era in pancreatic cancer management with significant clinical implications.

What is the treatment after BCMA CAR T failed in RR multiple myeloma cases
CAR T-Cell therapy

What is the treatment after BCMA CAR T failed in R/R multiple myeloma cases?

For people with relapsed or refractory multiple myeloma, BCMA CAR T-cell therapy might not work. Other treatments, such as bispecific antibodies, other CAR T-cell therapies that target different antigens, and combination regimens with immunomodulatory drugs, proteasome inhibitors, and monoclonal antibodies, can still be used. OriCAR-017 is another immunotherapy that is under trial and is expected to be launched soon. Clinical trials offer experimental treatments, providing access to novel therapies. Tailored approaches based on patient-specific factors and emerging research are crucial for improving outcomes in this challenging scenario.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy