FDA News

The FDA approved tepotinib (Tepmetko) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with MET exon 14-skipping alterations, according to the FDA.

The 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.

The FDA has granted toripalimab a fast track designation for use in the frontline treatment of patients with mucosal melanoma, according to an announcement from Junshi Biosciences, the drug developer.

The 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.

The FDA approved cabozantinib (Cabometyx) plus nivolumab (Opdivo) for the frontline treatment of patients with advanced renal cell carcinoma (RCC).

The 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.

The 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.

The 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.

The 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).

The 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.

The 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.

The FDA has approved an investigational new drug application for berubicin for the treatment of patients with glioblastoma multiforme.

This is the second COVID-19 vaccine to be granted Emergency Use Authorization by the FDA.

The FDA has approved ponatinib for the treatment of patients with chronic-phase chronic myeloid leukemia that is resistant or intolerant to at least 2 prior kinase inhibitors.

The 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.

The FDA has approved the oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx) as a treatment for patients with advanced prostate cancer.

The FDA approved selinexor (Xpovio) plus bortezomib and dexamethasone for the treatment of patients with myeloma who previously had at least 1 other treatment.

The 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.

The FDA approved atezolizumab plus cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma (MCL).

The FDA has granted a fast track designation for the PKCβ inhibitor enzastaurin for the treatment of patients with newly diagnosed glioblastoma.

The drug combination can be taken orally, at home.

A 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.

The 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.

The 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.

The FDA has approved pembrolizumab (Keytruda) or patients with recurrent or metastatic cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

The FDA has had a busy couple of weeks, approving new agents to treat a variety of cancers.