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 Approves Generic Pemetrexed for Nonsquamous NSCLC
August 26th 2020The FDA has approved a generic form of pemetrexed for intravenous administration as a single-agent in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) that has not progressed following 4 cycles of first-line platinum-based chemotherapy.
FDA Update on Breast Implant-Associated Lymphoma, Breast Implant Illness
August 24th 2020The Food and Drug Administration (FDA) provided an update on breast-implant associated side effects that have been reported to the agency, including breast implant-associated anaplastic large cell lymphoma (BI-ALCL) and symptoms that are commonly referred to by patients as breast implant illness (BII).
FDA Approves Daratumumab Plus Carfilzomib/Dexamethasone for Relapsed/Refractory Myeloma
August 21st 2020The FDA has approved daratumumab in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received 1 or more prior lines of therapy.
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.