On February 26, 2021, the Food and Drug Administration granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.
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.
The American Society of Clinical Oncology (ASCO) recently released the ASCO Oncology Clinician Well-Being Task Force Roadmap. The document outlines a five-year plan to improve the quality of cancer care by enhancing the wellbeing of oncology clinicians and sustainability of oncology practices.
The Association of Clinical Oncology congratulates the eleven practices that prioritized the quality of care they provide by achieving the Quality Oncology Practice Initiative (QOPI®) Certification in the second half of 2020.
On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.
As part of ASCO’s work to reduce the global burden of cancer, the Society is collaborating with the American College of Cardiology (ACC) to expand its NCD Academy to include a cancer course.
The American Society of Clinical Oncology’s (ASCO) Road to Recovery Report: Learning from the COVID-19 Experience to Improve Clinical Research and Cancer Care, among other recommendations, calls for the U.S. Department of Health and Human Services (HHS) to establish a special enrollment period on the federal health insurance exchange, abandon plans that limit access to healthcare, and enact policies that enhance access to care for patients with cancer. ASCO applauds the Biden administration for its recent actions supporting policies that aim to promote and protect access to high-quality, equitable cancer care, as outlined in the “Road to Recovery” report.
In the midst of growing concerns that patients with cancer have limited access to the COVID-19 vaccines, the Association for Clinical Oncology (ASCO) and American Cancer Society Cancer Action Network (ACS CAN), advocacy affiliate of the American Cancer Society, today issued a joint letter to every state governor in the United States urging them to prioritize patients with cancer in the distribution of COVID-19 vaccines in accordance with U.S. Centers for Disease Control and Prevention (CDC) guidelines.
ASCO has developed a free educational series to help the oncology community learn more about the role of social determinants of health in cancer care and cancer outcomes.
JCO Oncology Practice recently published an editorial that examines the intensified burnout oncology practitioners are experiencing due the COVID-19 pandemic and outlines critical interventions to support oncologists now and throughout a long-term recovery. The article was written by past, current, and select members of the American Society of Clinical Oncology’s (ASCO) Ethics Committee and Clinician Well-Being Task Force.
On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC) previously treated with a HHI or for whom a HHI is not appropriate.
The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) jointly issued new recommendations to further efforts to broaden eligibility criteria in cancer clinical trials with the goal of making clinical trials more accessible to patients. The joint recommendations are detailed in a series of articles published in Clinical Cancer Research, a journal of the American Association for Cancer Research. The series provides a comprehensive examination of eligibility criteria for cancer clinical trials with recommendations to address five specific areas: treatment washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and patient performance status.
On February 5, 2021, the Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the specific indications.
On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.
On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
President Biden signed an executive order (EO) that will reopen HealthCare.gov—the federal health insurance exchange—for a special, three-month enrollment period starting on February 15, 2021. The Association for Clinical Oncology (the Association) applauds this decision, which was a recommendation in American Society of Clinical Oncology’s (the Society) Road to Recovery Report: Learning from the COVID-19 Experience to Improve Clinical Research and Cancer Care. Reopening the federal health insurance exchange will help provide coverage to the millions of Americans who have lost their health insurance amid the COVID-19 pandemic.