Nivolumab is approved by the FDA for adjuvant treatment of Stage IIB/C melanoma

Nivolumab is approved by the FDA for adjuvant treatment of Stage IIB/C melanoma
The Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.

Share This Post

Nov 2023: Nivolumab (Opdivo, Bristol-Myers Squibb Company) was granted approval by the Food and Drug Administration as an adjuvant therapy for Stage IIB/C melanoma in patients 12 years of age and older who had undergone complete resection.

In the randomized, double-blind trial CHECKMATE-76K (NCT04099251), which included 790 patients with Stage IIB/C melanoma, efficacy was assessed. A placebo or 480 mg nivolumab was administered intravenously to patients in a randomized (2:1) fashion every four weeks for a maximum of one year, or until disease recurrence or unacceptable toxicity occurred.

A complete resection of the primary melanoma with negative margins and a negative sentinel lymph node within 12 weeks prior to randomization, as well as an ECOG performance status of 0 or 1, were prerequisites for enrollment. Patients who met the inclusion criteria for the trial did not have ocular/uveal or mucosal melanoma, autoimmune disease, any condition necessitating systemic treatment with corticosteroids (equivalent to or exceeding 10 mg of daily prednisone) or other immunosuppressive drugs, or prior melanoma therapy other than surgery. AJCC 8th staging system edition stratification of randomization was employed (T3b versus T4a versus T4b).

The primary efficacy outcome measure was recurrence-free survival (RFS), which the investigators defined as the time between randomization and the earliest of the following events—local, regional, or distant metastasis recurrence, new primary melanoma, or mortality (from any cause). Evaluations were performed at 26-week intervals from years one to three, and then every 52 weeks for the following five years. In both the nivolumab and placebo arms, the median RFS was not achieved (95% CI: 28.5, not reached; p-value<0.0001). The hazard ratio was 0.42 [95% CI: 0.30, 0.59]; p-value was less than 0.0001.

Mood swings, musculoskeletal pain, pruritis, rash, and diarrhea were the most frequently reported adverse effects (>20% of patients).

Patients weighing 40 kg or more are advised to take 240 mg of nivolumab every 2 weeks or 480 mg every 4 weeks until disease progression or unacceptable toxicity, for a maximum of one year. For up to one year, pediatric patients weighing less than 40 kg are prescribed a dosage of 3 mg/kg every two weeks or 6 mg/kg every four weeks, until disease progression or unacceptable toxicity occurs.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Risk of developing secondary tumors following CAR-T cell therapy is minimal - A Stanford Study
CAR T-Cell therapy

Risk of developing secondary tumors following CAR-T cell therapy is minimal – A Stanford Study

CAR-T cell therapy, a groundbreaking cancer treatment, carries a risk of developing secondary tumors. This occurs due to the therapy’s potential to cause genetic mutations or alter the immune system’s regulation. Secondary malignancies can arise from these changes, presenting a significant long-term risk for patients. Continuous monitoring and research are crucial to understanding and mitigating these risks, ensuring safer outcomes for those undergoing CAR-T cell therapy.

Seattle Children's Hospital to Start CAR T-Cell Clinical Trial for Pediatric Lupus Patients
CAR T-Cell therapy

Seattle Children’s Hospital to Start CAR T-Cell Clinical Trial for Pediatric Lupus Patients

Seattle Children’s Hospital is launching a groundbreaking CAR T-cell clinical trial for pediatric lupus patients. This innovative approach harnesses the body’s immune cells to target and eliminate lupus-affected cells, offering new hope for young patients with this autoimmune disorder. The trial represents a significant advancement in lupus treatment, aiming to improve outcomes and reduce long-term complications for children suffering from this challenging condition.

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