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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The Association for Clinical Oncology (ASCO) responded to the Centers for Medicare & Medicaid Services (CMS) Request for Information (RFI) on electronic prescribing of controlled substances (EPCS). ASCO supports safe and unburdened access to opioids for people with cancer and asserts that EPCS provides benefits that can improve the quality of cancer care.
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.
On September 13, President Trump signed an executive order (EO) aiming to address high prescription drug prices by tying payments for certain Medicare drugs to the costs the treatments sell for outside the United States (U.S.). According to the EO, prices for provider-administered drugs would be linked to a "most-favored-nation price" drawn from the lowest price among countries that have a similar per-capita gross domestic product.
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.
On September 2, the Centers for Medicare & Medicaid Services (CMS) released updates to the Inpatient Prospective Payment System (IPPS) final rule for fiscal year 2021, including updates to Medicare payment policies and payment rates for most acute care hospitals. Notably, CMS finalized its proposal to establish a Medicare Severity Diagnosis Related Group (MS-DRG) for chimeric antigen receptor T-cell (CAR-T) services.
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.
The American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC) today announced a new collaboration to foster participation in cancer treatment trials to more fully reflect the diversity of people at risk for or living with cancer.
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).