On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior 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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UPDATE: On Tuesday, April 13, 2021, the House passed the Senate bill to extend the moratorium on the 2% Medicare sequestration cuts through the end of the calendar year. President Biden signed the bill into law on Wednesday, April 14, 2021. CMS has resumed processing claims.
Both chambers of the United States Congress recently passed separate bills to extend the temporary moratorium on the 2% sequestration cut to Medicare reimbursement. The moratorium is currently set to expire on March 31, 2021, and both bills would extend the moratorium until December 31, 2021. However, since the House and Senate legislation differ, further action is needed before the extension becomes law.
The Association for Clinical Oncology (ASCO) is holding its 2021 ASCO Advocacy Summit Week of Action from April 12-16. During the Week of Action, ASCO members can visit ASCO’s easy-to-use ACT Network to quickly and efficiently contact their lawmakers to urge them to take action on cancer policy priorities.
On March 26, 2021, the Food and Drug Administration approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. This is the first FDA-approved cell-based gene therapy for multiple myeloma.
Beginning April 1, additional savings may be available for new and current consumers who purchase health insurance on HealthCare.gov following passage of the American Rescue Plan. The Centers for Medicare & Medicaid Services (CMS) also extended access to the Special Enrollment Period (SEP) for the federally funded health insurance marketplace until August 15, to provide additional time for consumers to enroll or make changes to their coverage with the tax credits that become available April 1.
The Association for Clinical Oncology joined the Prevent Cancer Foundation® and more than 300 other organizations from across the country in signing a letter to convey support for the Medicare Multi-Cancer Early Detection Screening Coverage Act.
On March 22, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chemoradiation.
The Association for Clinical Oncology (ASCO) congratulates Xavier Becerra on his confirmation as Secretary of the Department of Health and Human Services (HHS). Secretary Becerra is now in a key position to lead HHS during the agency’s continued response to the COVID-19 pandemic and to address the many challenges facing patients and providers across the cancer care delivery system, such as health care disparities and the high cost of care.
On Thursday, March 11, President Biden signed a $1.9 trillion COVID-19 relief package into law. The legislation, known as the American Rescue Plan, allocates money for vaccines, schools, small businesses and anti-poverty programs such as an expanded child tax credit that would mean new monthly payments to many parents.
The latest issue of JCO Oncology Practice features a new Special Series of articles examining the disparities and barriers faced in cancer care. The articles detail challenges experienced by people of different cultures, backgrounds, ages, and socioeconomic factors, and provides a framework for addressing disparities in underserved communities.
On March 10, 2021, the Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
On March 5, 2021, the Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.
The Association for Clinical Oncology (ASCO) endorsed the “PREVENT HPV Cancers Act” (H.R. 1550), which was recently introduced by Representative Kathy Castor (FL-14).
On March 3, 2021, the Food and Drug Administration granted regular approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, detected by an FDA-approved test.
The Association for Clinical Oncology, as part of the Cancer Leadership Council, sent a letter to the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) offering the group’s perspective on progress to date in the effort to vaccinate people with cancer and other serious health concerns against COVID-19.