On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.
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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On Friday, April 9, ASCO and Friends of Cancer Research (Friends) co-hosted a live virtual event, which brought together experts from across the healthcare sector to discuss the recent release of the new ASCO-Friends recommendations for modernizing eligibility criteria to improve patient access and representation in cancer clinical trials. ASCO-Friends recommendations address five specific areas: treatment washout periods, concomitant medications, prior therapies, laboratory reference ranges and test intervals, and patient performance status.
The Association for Clinical Oncology (ASCO) applauds the proposed $9 billion funding increase for the National Institutes of Health (NIH) in President Biden’s budget request for Fiscal Year (FY) 2022. Such a significant proposed investment in biomedical research demonstrates a real commitment from the Administration to supporting the nation’s research infrastructure.
On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
As part of its ongoing efforts to increase the diversity of the oncology workforce, the American Society of Clinical Oncology (ASCO) is launching a new internship program for medical students from populations underrepresented in medicine (UIM)1, and today announced five medical schools across the country that have been selected to serve as hosts in the inaugural Oncology Summer Internship (OSI) program. The selected medical schools include: The Ohio State University; the University of Arizona Health Sciences College of Medicine – Tucson; the University of California San Francisco (UCSF); the University of Pittsburgh; and the University of Rochester.
On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).
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.
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 is expected to sign the bill into law.
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. The legislation would allow the Centers for Medicare & Medicaid Services to evaluate and cover multi-cancer early detection tests once they are approved by the Food and Drug Administration.
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.
The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) will jointly host a virtual meeting on April 9 to build on efforts to broaden eligibility criteria to make clinical trials more representative.