On May 28, 2021, the Food and Drug Administration granted accelerated approval to sotorasib (Lumakras™, Amgen, Inc.), a RAS GTPase family inhibitor, for adult patients with KRAS G12C‑mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA‑approved test, who have received at least one prior systemic 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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A recording is now available of a virtual roundtable focused on achieving equity in precision cancer care. The event was hosted by the American Society of Clinical Oncology (ASCO).
Administrator Brooks-LaSure is now in a key position to lead CMS during the agency’s continued response to the COVID-19 pandemic and the evolving implementation of the Affordable Care Act (ACA) under the new Administration.
ASCO has been notified of a recent safety notice relating to the drug BLINCYTO® (blinatumomab) under the Food and Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy (REMS) program.
The Centers for Medicare & Medicaid Services (CMS) recently announced updates to the Merit-based Incentive Payment System (MIPS) under the Quality Payment Program (QPP). The agency reweighted the 2020 MIPS cost performance category, opened applications for the 2021 MIPS promoting interoperability performance category hardship and extreme and uncontrollable circumstances exceptions, and released MIPS Cost measure benchmarks.
The Improving Senior’s Timely Access to Care Act (H.R. 3173) was recently re-introduced in the U.S. House of Representatives by Reps. Suzan DelBene (WA), Mike Kelly (PA), Dr. Ami Bera (CA), and Larry Bucshon (IN). The bill aims to streamline prior authorization practices and reduce care delays within the Medicare Advantage (MA) program.
On May 21, 2021, the Food and Drug Administration granted accelerated approval to amivantamab-vmjw (Rybrevant, Janssen Biotech, Inc.), a bispecific antibody directed against epidermal growth factor (EGF) and MET receptors, for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
On May 20, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
A new special series in JCO Oncology Practice, a journal of the American Society of Clinical Oncology (ASCO), explores the causes of disparities in cancer care and outcomes for Black people in the United States and examines potential solutions to begin to achieve health equity for this population.
On May 10, 2021, the Department of Health and Human Services’ (HHS) Office for Civil Rights announced that its ban on sex discrimination once again includes a ban on discrimination on the basis of sexual orientation and gender identity. The move will reverse a final rule from June 2020 that established a narrowed definition of sex that protected against discrimination only on the basis of "biological sex."
The Association for Clinical Oncology (ASCO) submitted comments to a House Ways and Means Health Subcommittee hearing titled “Charting the Path Forward for Telehealth.” The comments convey ASCO’s views on how telehealth can better serve individuals with cancer and the oncology professionals who care for them.
The U.S. Food and Drug Administration (FDA) announced plans to advance two proposed tobacco product standards within the next year that would ban menthol cigarettes and flavored cigars (including menthol-flavored cigars) from the marketplace in the United States. The proposed standards align with the American Society of Clinical Oncology’s recommendation that FDA ban the addition of menthol to cigarettes and other combustible tobacco products as a characterizing flavor.
On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
In a continuation of their collaboration to increase clinical trial participation among patients from underrepresented racial and ethnic groups, the American Society of Clinical Oncology (ASCO) and Association of Community Cancer Centers (ACCC) today announced plans to test a research site assessment tool and implicit bias training program, both of which are designed to address one of the barriers to clinical trial participation: trials not routinely being offered by clinicians to eligible patients.
The Centers for Medicare & Medicaid Services released part two of the Notice of Benefit and Payment Parameters for 2022 and Pharmacy Benefit Standards final rule.