On October 14, 2020, the Food and Drug Administration extended the approval of pembrolizumab (KEYTRUDA®, Merck Sharp & Dohme Corp.) for the following indications: adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) and pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.
ASCO in Action provides the latest news and analysis related to critical policy issues affecting the cancer community, updates on the Association for Clinical Oncology’s ongoing advocacy efforts, and opportunities for members and others in the cancer care community to take action.
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On October 2, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) as first-line treatment for adult patients with unresectable malignant pleural mesothelioma.
The Continuing Resolution provides flat funding for the National Institutes of Health (NIH), the National Cancer Institute (NCI), and the Food and Drug Administration (FDA) through December 11, 2020, and does not include any emergency or additional funding for the NIH to mitigate disruptions to trials/research due to COVID-19.
The Association for Clinical Oncology (ASCO) submitted comments to the Food and Drug Administration (FDA) in response to its Proposed Rule – Annual Summary Reporting Requirements Under the Right to Try Act, which proposes a statutory requirement where sponsors and manufacturers must provide an annual summary of any investigational drugs supplied for use to an eligible patient.
The Reagan-Udall Foundation for the FDA, with input from experts at FDA, launched Expanded Access eRequest to streamline expanded access for individual patients in non-emergency settings.
On September 4, 2020, the Food and Drug Administration granted accelerated approval to pralsetinib (GAVRETOTM, Blueprint Medicines Corporation) for adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
The Association for Clinical Oncology (ASCO) today released a statement regarding concerns that the U.S. Department of Health and Human Services (HHS) rescission of all guidance and informal issuances related to the Food and Drug Administration’s (FDA) current oversight of the premarket review and approval process for laboratory developed tests (LDTs) puts the safety of cancer treatments at risk.
ASCO has been notified about a recent safety update relating to the drug COPIKTRATM (duvelisib) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.
On September 1, 2020, the Food and Drug Administration approved azacitidine tablets (ONUREG®, Celgene Corporation) for continued treatment of patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
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.
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.