Kristi Rosa

The FDA has approved the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients who are 12 years of age or older and who have unresectable or metastatic melanoma.

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma.

The FDA has expanded the label for pembrolizumab for use as a monotherapy in the treatment of patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

The FDA has granted an orphan drug designation to the orally bioavailable, highly-specific G protein-coupled estrogen receptor agonist LNS8801 for the treatment of patients with metastatic uveal melanoma.

The FDA has approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.