FDA Approves Pembrolizumab for Advanced Esophageal/GEJ Cancer
March 22nd 2021The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.
Belzutifan Granted Priority Review for VHL Disease–Associated RCC
March 17th 2021The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.
FDA to Reassess Accelerated Immunotherapy Approvals
March 12th 2021Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.
Tipifarnib Gets Breakthrough Therapy Designation for HRAS-Mutated HNSCC
February 25th 2021The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.
Vicineum Granted Priority Review for High-Risk, BCG-Unresponsive Bladder Cancer
February 18th 2021The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.
Sotorasib Granted Priority Review for KRAS G12C–Mutated Advanced or Metastatic NSCLC
February 17th 2021The FDA has granted priority review to sotorasib for the treatment of patients with KRAS G12C–mutated locally advanced or metastatic non–small cell lung cancer, after at least 1 previous systemic therapy.
FDA Approves Trilaciclib for Chemo-Induced Bone Marrow Suppression in Small Cell Lung Cancer
February 12th 2021The FDA has approved trilaciclib to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.
Ilixadencel Gets Orphan Drug Designation for Soft Tissue Sarcoma
January 27th 2021The FDA has granted the cell-based, off-the-shelf immune primer ilixadencel an orphan drug designation for use as a treatment option in patients with soft tissue sarcoma (STS), according to an announcement from Immunicum AB.
Retifanlimab Granted Priority Review for Squamous Cell Carcinoma of the Anal Canal
January 23rd 2021The FDA has granted priority review to a biologics license application (BLA) for retifanlimab (INCMGA 0012) for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who were intolerant of or who had progressed on platinum-based chemotherapy.
Nivolumab/Chemo Granted Priority Review for Frontline Metastatic Gastric, GEJ, and Esophageal Cancer
January 20th 2021The FDA has granted a priority review to a supplemental biologics license application for nivolumab (Opdivo) in combination with a fluoropyrimidine- and platinum-containing chemotherapy for use in patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma.
Padeliporfin ImPACT Granted Fast Track Status for Upper-Tract Urothelial Cancer
January 19th 2021The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for HER2+ Gastric Adenocarcinomas
January 16th 2021The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with locally advanced or metastatic HER2-postive gastric or gastroesophageal (GEJ) adenocarcinoma who previously received a trastuzumab-based regimen.
Cavrotolimod Granted Fast Track Status for Merkel Cell Carcinoma, CSCC
January 12th 2021The FDA has granted fast track designations to cavrotolimod (AST-008) for use in combination with a PD-1 therapy in patients with locally advanced or metastatic Merkel cell carcinoma (MCC) that is refractory to previous PD-1 blockade and for use in combination with a PD-1/PD-L1 agent in those with advanced or metastatic cutaneous squamous cell carcinoma (CSCC) that is refractory to previous PD-1/PD-L1 blockade.