Cosibelimab

The FDA approved cosibelimab for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC), supported by Study CK-301-101 showing a 47.4% objective response rate (ORR) in 78 patients with metastatic cSCC. The anti–PD-L1 antibody demonstrated ongoing responses in 73% of patients, with common adverse events including fatigue, rash, and anemia. The approval was based on clinical data, with no concerns regarding safety or labeling.

The FDA approved cosibelimab (Unloxcyt) for advanced cutaneous squamous cell carcinoma (CSCC), the first PD-L1 blocker for this use. It helps the immune system detect and attack cancer cells by blocking PD-L1 protein. In a trial, tumors shrank in 47-48% of patients. Common side effects include tiredness, muscle pain, and thyroid issues. The drug can cause serious immune-related side effects and harm unborn babies.

The FDA approved cosibelimab-ipdl for treating metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) in adults not eligible for curative surgery or radiation. Efficacy and safety were demonstrated in the CK-301-101 trial. Cosibelimab, a PD-L1 blocking antibody, showed clinically meaningful objective response rate (ORR) and duration of response (DOR) with a manageable safety profile. The recommended dose is 1200 mg IV every 3 weeks.

The FDA approved cosibelimab for locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) patients not candidates for curative surgery or radiotherapy, based on phase 1 trial results showing 47% objective response rate (ORR) for metastatic disease and 48% for locally advanced disease. The decision follows a resubmitted BLA in July 2024, addressing issues from a previous complete response letter (CRL) in December 2023.

The FDA approved cosibelimab-ipdl (Unloxcyt) for metastatic or locally advanced cutaneous squamous cell carcinoma, based on a phase 1 study showing ORR of 47% and 48% in metastatic and locally advanced disease, respectively. Unloxcyt binds to PD-L1, offering a differentiated treatment option. Safety data revealed common AEs and laboratory abnormalities.

The FDA is set to decide on ten drug applications, including Ionis' olezarsen for familial chylomicronemia syndrome, Lexicon's sotagliflozin for type 1 diabetes, AstraZeneca and Daiichi Sankyo's Dato-DXd for non-squamous NSCLC, Zealand Pharma's glepaglutide for short bowel syndrome, Rhythm Pharmaceuticals' Imcivree for genetic obesity in children, Checkpoint Therapeutics' cosibelimab for cutaneous squamous cell carcinoma, Mirum's chenodiol for cerebrotendinous xanthomatosis, Bristol Myers Squibb's subcutaneous Opdivo, and Neurocrine's crinecerfont for congenital adrenal hyperplasia.

FDA decisions in December include BeiGene's Tevimbra for gastric cancer, Ionis Pharma's Olezarsen for familial chylomicronemia syndrome, Lexicon Pharma's Zynquista for type 1 diabetes, AstraZeneca's Datopotamab deruxtecan for lung cancer, Zealand Pharma's Glepaglutide for short bowel syndrome, Rhythm Pharma's IMCIVREE for obesity in children, Soleno's DCCR for Prader-Willi syndrome, Checkpoint's Cosibelimab for skin cancer, Mirum's Chenodiol for cerebrotendinous xanthomatosis, Bristol-Myers' subcutaneous Opdivo, and Neurocrine's Crinecerfont for congenital adrenal hyperplasia.

Oncolytics Biotech Inc. announces key progress and upcoming studies for breast and pancreatic cancer treatments, preparing for FDA accelerated approval. The company's lead intravenously administered immunotherapy, pelareorep, shows promising efficacy in ongoing trials, with plans to initiate a clinical trial to support accelerated FDA approval in 2025.

Fortress Biotech announces FDA approval for Emrosi to treat rosacea and potential approval for cosibelimab for cutaneous squamous cell carcinoma, with financial results and recent corporate highlights for Q3 2024.