ASCO in Action

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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Tune in to the ASCO in Action podcast series for analysis and commentary on cancer policy and practice issues. The podcast is available through iTunes or Google Play.

May 12, 2020

The Association for Clinical Oncology (ASCO) recently submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s draft guidance to encourage the inclusion of older adults in clinical trials of cancer drug treatments.

May 11, 2020

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for the following indications:

May 6, 2020

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTATM, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

May 1, 2020

On April 30, the Centers for Medicare & Medicaid Services (CMS) released a second Interim Final Rule establishing new regulatory waivers and rule changes to increase flexibility for health care providers during the COVID-19 public health emergency (PHE). These waivers and rule changes further aim to expand telehealth, make it easier for Medicare and Medicaid beneficiaries to get tested for COVID-19, increase hospital capacity, augment the health care workforce, and decrease administrative burden.

May 1, 2020

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPROTM, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab.

May 1, 2020

The Centers for Medicare & Medicaid Services (CMS) has confirmed ASCO’s Survey on COVID-19 in Oncology Registry (ASCO Registry) is an acceptable clinical trial registry for the attestation of the high-weighted practice Improvement Activity (IA), “COVID-19 Clinical Trials related to the Emergency Response & Preparedness,” under the Merit-based Incentive Payment System (MIPS).

April 29, 2020

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

April 29, 2020

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On April 28, 2020, the Food and Drug Administration granted accelerated approval to a new dosing regimen of 400 mg every six weeks for pembrolizumab (KEYTRUDA®, Merck) across all currently approved adult indications, in addition to the current 200 mg every three weeks dosing regimen.

April 28, 2020

The latest legislative package aimed at stabilizing the United States (U.S.) economy and bolstering the health care system during the COVID-19 crisis was recently signed into law.

April 28, 2020

On April 26, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance

Payment Program to Part B suppliers effective immediately. Beginning on April 26, 2020, CMS will not be accepting any new applications for the Advance Payment Program, and CMS will be reevaluating all pending and new applications for Accelerated Payments.  

April 28, 2020

The Association for Clinical Oncology (ASCO) joined hundreds of other health organizations in signing onto four separate letters to Congress regarding future COVID-19 legislation as part of an effort to ensure patient access to high-quality, high-value cancer care during the pandemic. The four comment letters address different areas of cancer care delivery system:  

April 27, 2020

A MedWatch Safety Alert was added to the FDA MedWatch webpage.

TOPIC: Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems

AUDIENCE: Consumer, Patient, Critical Care Medicine, Infectious Disease, Health Professional

April 24, 2020

On April 22, HHS announced the allocation of an additional $40.4 billion from the Public Health and Social Services Emergency Fund.

April 23, 2020

The American Society of Clinical Oncology (the Society) and its affiliate organization the Association for Clinical Oncology (the Association) today announced the results of a survey that tracked the initial impact of the COVID-19 pandemic on cancer clinical trials, highlighted a new research initiative to address the data gap on the coronavirus’ effect on individuals with cancer, and set forth a road to recovery as the cancer care delivery system prepares for life after COVID-19.

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