Cosibelimab

In 2024, the FDA approved over 60 oncology therapies, including 11 first-in-class drugs. Highlights include Revumenib and Zolbetuximab for leukemia and gastric cancer, respectively, and new treatments targeting HER2, PD-L1, and ALK with improved efficacy and reduced toxicity. The approvals also featured novel strategies like bispecific antibodies and CAR T-cell therapies, alongside new indications for existing drugs.

In December 2024, FDA approved several treatments including zenocutuzumab for NRG1+ NSCLC and pancreatic cancer, cosibelimab for CSCC, and combinations for BRAF V600E+ mCRC. Fast track and breakthrough designations were granted for treatments in MDS, cervical cancer, NSCLC, and SCLC. Priority reviews were given for taletrectinib in ROS1+ NSCLC and remestemcel-L for pediatric acute GVHD.

In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.

FDA approved treatments in December 2024 include durvalumab for small cell lung cancer, zenocutuzumab for NRG1+ NSCLC and pancreatic adenocarcinoma, cosibelimab for cutaneous squamous cell carcinoma, ensartinib for ALK+ NSCLC, encorafenib plus cetuximab for BRAF V600E+ metastatic colorectal cancer, tislelizumab plus chemo for PD-L1+ gastric/GEJ cancer, and subcutaneous nivolumab for advanced solid tumors.

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.