FDA News

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 rituximab-arrx for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

The FDA has lifted the clinical hold placed on the phase 1 PSMA-101-001 study (NCT04249947) of the CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.

The FDA approved pembrolizumab for the treatment of adults with relapsed or refractory classical Hodgkin lymphoma.

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 has approved the FoundationOne Liquid CDx, a liquid biopsy for all solid tumors with multiple companion diagnostic indications.

The 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.

The 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).

The FDA has granted a fast track designation to paxalisib for the treatment of patients with glioblastoma.

The 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.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of approving remestemcel-L for the treatment of children with steroid-refractory acute graft-versus-host disease.

The FDA has approved Guardant360® CDx for comprehensive genomic profiling in patients with any solid malignant cancer.

The FDA granted an orphan drug designation to the oral investigational modified proprietary tyrosine derivative SM-88 as a treatment for patients with pancreatic cancer.

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.