FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer March 4, 2025
FDA Grants Priority Review to KEYTRUDA + SOC as Perioperative Treatment for Resectable Locally Advanced SCCHN; PDUFA: Jun 23, 2025 March 4, 2025
Petosemtamab granted Breakthrough Therapy designation by the US FDA for 1L PD-L1 positive head and neck squamous cell carcinoma February 25, 2025
ASCO-GU 2025: CRB-701 (SYS6002) Demonstrates Encouraging Safety and Broader Efficacy in Ph 1 Study February 19, 2025
First Patients Enrolled in FORTIFI-HN01, Ph 2/3 Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma February 17, 2025
Positive interim Alpha DaRT data from multiple clinical trials in pancreatic cancer, a combination study with pembrolizumab in patients with recurrent unresectable or metastatic HNSCC, and other clinical trials announced February 4, 2025
Global Ph 3 Trial of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab for 1L Recurrent Head and Neck Cancer initiated January 28, 2025
Tagitanlimab Approved by NMPA in Combination with Cisplatin and Gemcitabine For the 1L Treatment of Patients with recurrent or metastatic NPC January 28, 2025
Pyxis Oncology Announces Portfolio Prioritization, Focusing Resources on PYX-201 program December 26, 2024
Data shows strong OS, PFS, and durability from combination of efti + pembrolizumab in difficult-to-treat head and neck cancer patients with PD-L1 CPS <1 December 18, 2024
Petosemtamab Monotherapy Interim Data Continues to Demonstrate Clinically Meaningful Activity in 2L+ r/m HNSCC December 10, 2024
Enrollment of 68 patients completed in Ph 2 study for eseba-vec + pembrolizumab in HPV+ HNSCC four months ahead of schedule November 26, 2024
UK MHRA approved toripalimab (LOQTORZI®)-chemo combos for the 1L treatment of metastatic NPC and unresectable advanced, recurrent, or metastatic ESCC November 19, 2024
U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025 November 13, 2024
AKIR001 cleared to start Ph 1 clinical trial in multiple cancer types, including anaplastic and iodine-refractory thyroid cancer, SCCHN, and NSCLC November 5, 2024
First Patient Enrolled in Ph 3 Trial of Ivonescimab + Ligufalimab for 1L Treatment of HNSCC Compared to Pembrolizumab November 5, 2024
FDA’s Oncologic Drugs Advisory Committee Decision on use of Multikine® in PD-L1 Negative Cancer Patients announced October 29, 2024
KEYTRUDA Met Primary Endpoint of EFS as Perioperative Treatment Regimen in Patients With Resected, Locally Advanced SCCHN October 15, 2024
Exelixis and Merck to Evaluate Zanzalintinib in Combination With KEYTRUDA in Head and Neck Cancer and in Combination With WELIREG in RCC October 15, 2024
First patient enrolled in Ph 1/2a clinical trial for Lenti-HPV07 against oropharyngeal and cervical cancers October 15, 2024
FDA IND Clearance for ALE.P02, a Novel CLDN1-ADC for the Treatment of Squamous Cancers October 8, 2024
EC approved toripalimab (LOQTORZI®) for the treatment of certain patients with mNPC and ESCC October 2, 2024
Strategic Repositioning of VB10.16 to Focus on Locally Advanced Cervical Cancer and Recurrent Metastatic Head and Neck Cancer August 27, 2024
FDA granted Fast Track Designation to APG-157 for the neoadjuvant treatment of Head and Neck Cancer (HNC) August 27, 2024
