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.
FDA Approves Crizotinib for Pediatric/Young Adult ALK+ Anaplastic Large Cell Lymphoma
January 15th 2021The FDA has approved crizotinib (Xalkori) for the treatment of pediatric patients 1 year of age and older and young adults with ALK-positive relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL).
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.
ADC ARX788 Gets Fast Track Status for HER2+ Metastatic Breast Cancer
January 6th 2021The FDA has granted a fast track designation to the investigational antibody-drug conjugate (ADC) ARX788 for use as a monotherapy in the treatment of patients with advanced or metastatic HER2-positive breast cancer who have previously received 1 or more HER2-targeted regimens in the metastatic setting.
Adjuvant Osimertinib Approved for EGFR-Positive Lung Cancer
December 19th 2020The FDA has approved osimertinib (Tagrisso) for use as an adjuvant treatment following tumor resection in patients with non–small cell lung cancer whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
FDA Approves Copper Cu 64 Dotatate Injection for Somatostatin Receptor-Positive NETs
September 10th 2020The FDA has approved copper Cu 64 dotatate injection (Detectnet) for the localization of somatostatin receptor–positive neuroendocrine tumors (NETs), according to an announcement from RadioMedix Inc. and Curium Pharma.
FDA Approval Sought for Pralsetinib to Treat Advanced RET+ Thyroid Cancers
July 2nd 2020A new drug application (NDA) has been submitted to the FDA for pralsetinib (BLU-667) for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion–positive thyroid cancers, according to an announcement from Blueprint Medicines, the developer of the drug.
FDA Approves Frontline Pembrolizumab for MSI-H/dMMR Metastatic CRC
June 30th 2020The FDA has approved pembrolizumab (Keytruda) for the first-line treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.
FDA Approves Phesgo, an In-Home Breast Cancer Treatment
June 29th 2020The FDA approved subcutaneous Phesgo – a combination of pertuzumab (Perjeta), trastuzumab (Herceptin), and hyaluronidase–zzxf – for the treatment of patients with metastatic HER2-positive breast cancer, as well as early-stage HER2-positive breast cancer, as selected by an FDA-approved companion diagnostic test.