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.

To sign up for advocacy alerts, log in to ASCO.org with your member or guest account, and visit the subscription center available under your account profile.

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 15, 2020

ASCO has been notified about a recent safety update relating to the drug BLINCYTO® (blinatumomab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.

May 14, 2020

On May 7, the Centers for Medicare & Medicaid Services (CMS) released the Patient Protection and Affordable Care Act 2021 Notice of Benefit and Payment Parameters final rule, which updates the regulatory and financial standards for Affordable Care Act (ACA) Exchanges. The rule finalized a policy that gives insurers the discretion to not count any form of direct support from drug manufacturers to enrollees for specific prescription drugs toward the annual limit on patient cost sharing amounts.

May 12, 2020

On May 11, the Centers for Medicare & Medicaid Services (CMS) released the Hospital Inpatient Prospective Payment System (IPPS) proposed rule for 2021. Of particular note, CMS is proposing a new Medicare Severity-Diagnosis Related Group (MS-DRG) for chimeric antigen receptor T-cell therapy (CAR T-cell therapy).

May 12, 2020

ALEXANDRIA, Va. -- Twenty-seven practices elevated their standard of care and achieved Quality Oncology Practice Initiative (QOPI®) Certification in the first quarter of this year. The Association for Clinical Oncology (Association) commends these practices that have demonstrated their commitment to providing the highest-quality oncology care to their patients, communities, and contemporaries.

May 12, 2020

In the midst of the COVID-19 pandemic, a new ASCO article reports that oncology research programs are experiencing delays and other challenges in advancing clinical trials during this unprecedented time. The article, which published today in JCO Oncology Practice and was previewed during ASCO’s recent presscast on COVID-19 and cancer care, looks at the types of changes and challenges to clinical trials that research sites experienced early in the pandemic. Data from the article comes from a March 2020 survey of oncology research programs, including both academic- and community-based research programs.

May 12, 2020

The Association for Clinical Oncology (ASCO) recently sent a letter to House and Senate leadership urging their support for policies to increase diversity in clinical trials, including the CLINICAL TREATMENT Act (H.R. 913), in a future COVID-19 response package.

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

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).

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

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.

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 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.

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