On August 20, 2020, the Food and Drug Administration approved carfilzomib (KYPROLIS, Onyx Pharmaceuticals, Inc.) and daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
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The Association for Clinical Oncology (ASCO) today released a statement applauding the implementation of the Research to Accelerate Cures and Equity (RACE) for Children Act. As of today, applications to the Food and Drug Administration for marketing approval of new drugs and biological products—including orphan drugs that have relevance to pediatric cancer—must include an assessment of pediatric use.
On August 5, 2020, the Food and Drug Administration approved belantamab mafodotin-blmf (Blenrep, GlaxoSmithKline) for adult patients with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
On July 30, 2020, the Food and Drug Administration approved atezolizumab (Tecentriq, Genentech, Inc.) in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
On July 24, 2020, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by the FDA for the treatment of MCL.
The US Food and Drug Administration (FDA) recently finalized four new final Guidance for Industry documents for cancer clinical trial eligibility criteria that describe ways that clinical trials can safely include patients who have historically been excluded. The guidance documents complement ongoing work by ASCO and Friends of Cancer Research (Friends) to eliminate overly restrictive eligibility criteria that can exclude patients from trials without scientific or participant safety justification. Clinical trials provide patients with cancer access to promising investigational therapies – which are sometimes the only treatment option available – and advance clinical care by producing safety and efficacy data about new therapies.
The American Society of Clinical Oncology (ASCO) and the U.S. Food and Drug Administration (FDA) will be holding the 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop, which will be fully virtual. The goal of the workshop is to provide a detailed discussion for creating regulatory-grade patient-reported data on tolerability.
On July 7, 2020, the Food and Drug Administration approved an oral combination of decitabine and cedazuridine (INQOVI, Astex Pharmaceuticals, Inc.) for adult patients with myelodysplastic syndromes (MDS).
On June 30, 2020, the Food and Drug Administration approved avelumab (BAVENCIO®, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
On June 29, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
On June 29, 2020, the Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (PHESGO®, Genentech, Inc.) for subcutaneous injection.
On June 24, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
On June 22, 2020, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.
On June 18, 2020, the Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK™, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.