Cosibelimab

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.

Oncology dominates pharmaceutical innovation, with 1,600 cancer drugs in development. Spending on cancer drugs is projected to reach $409 billion by 2028, with high costs for novel agents. Biosimilars and generics may provide savings but cannot match rising expenditures. The focus is shifting towards cell therapies for solid tumors, with 44% of trials initiated in 2023 targeting solid tumor indications. Several cancer drugs have been approved by the FDA this year, and many more are expected to receive approval decisions soon.

In July 2024, the FDA made significant strides in cancer treatment approvals and designations, including the approval of FoundationOne Liquid CDx for BRCA-mutated mCRPC and Guardant Shield for colorectal cancer detection. Fast track designations were granted to therapies like OBX-115 for melanoma and AIC100 for thyroid cancer. The FDA also accepted BLAs for treatments targeting SR-aGVHD and EBV+ PTLD, and mandated phase assessments for NSCLC perioperative regimens, aiming to improve patient outcomes.