On April 5, 2022, the Food and Drug Administration granted accelerated approval to alpelisib (Vijoice, Novartis Pharmaceuticals) for adult and pediatric patients two years of age and older with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require 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.
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.
On April 5, CancerLinQ® and Count Me In announced a new collaboration that aims to allow cancer researchers to learn from every patient with cancer by actively engaging patients as part of the clinical research enterprise.
The Association for Clinical Oncology (ASCO) congratulates Dr. Norman E. “Ned” Sharpless on his successful tenure as Director of the National Cancer Institute (NCI). During his five years at NCI, Dr. Sharpless guided the Institute to advance the goals of the Cancer Moonshot Initiative, including important work to modernize cancer clinical trials to reflect an improved understanding of biology and the new types of therapies available to treat cancer. We are hopeful that these efforts will endure even after Dr. Sharpless’ departure later this month.
On March 18, ASCO and the European Cancer Organisation (ECO) hosted a free, open access webinar, “ASCO/ECO Briefing: Cancer Care During the War in Ukraine.” The goal was to provide a forum for getting an update on the Ukrainian refugee situation; hearing reports from oncologists in Ukraine, Poland, and Romania on the impact of the war on the care of patients with cancer; sharing resources and networks developed by the American Cancer Society (ACS), ASCO, and ECO to support oncology clinicians and their patients in the region; and learning about opportunities to assist Ukrainian patients and health care providers.
President Biden’s Fiscal Year (FY) 2023 budget request includes $5 billion for the Advanced Research Projects Agency for Health (ARPA-H), the proposed new biomedical research agency focused on high-risk, bold, translational research projects. While the Association for Clinical Oncology (ASCO) strongly believes in the stated mission of ARPA-H, we are concerned that the Administration’s FY 2023 budget request invests in ARPA-H at the expense of the National Institutes of Health (NIH) and the National Cancer Institute (NCI).
The Association for Clinical Oncology (ASCO) submitted comments to the Office of the National Coordinator for Health Information Technology (ONC) in response to the agency’s Request for Information (RFI) on electronic prior authorization (ePA).
On March 23, 2022, the Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, Advanced Accelerator Applications USA, Inc., a Novartis company) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
On March 21, 2022, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
On March 18, 2022, the Food and Drug Administration approved nivolumab and relatlimab-rmbw (Opdualag, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Opdualag is a fixed-dose combination of the LAG-3-blocking antibody relatlimab and the programmed death receptor-1 blocking antibody nivolumab.
Congress is considering several cancer policy priorities this week, including the PREVENT Pandemics Act, Cures 2.0, and legislation to authorize ARPA-H.
On March 17, the American Society of Clinical Oncology (ASCO) is hosting a meeting with key research stakeholders to discuss possible solutions and calls-to-action to optimize cancer clinical trials and facilitate routine patient access to trials closer to where they live.
The Association for Clinical Oncology (ASCO) is holding its annual Advocacy Summit Week of Action from April 4-8, during which ASCO members are encouraged to connect with their Members of Congress about policies and legislation that impact cancer care and research.
The National Academies of Sciences, Engineering, and Medicine (NASEM) issued a new report recommending the National Institutes of Health (NIH) implement new guidelines to standardize the collection of data on sex, gender, and sexual orientation.
The American Society of Clinical Oncology (ASCO) is currently accepting applications for its project to improve rates of recommended vaccinations for adults with cancer. The project is part of a five-year cooperative agreement between the Centers for Disease Control and Prevention (CDC) and the Council of Medical Specialty Societies (CMSS). ASCO will select seven participants for the project in the Spring of 2022.
The U.S. Food and Drug Administration and the American Society of Clinical Oncology are holding a free virtual workshop, May 3 - 5, on dose optimization for anticancer drug treatment. This timely workshop will bring together thought leaders from academia, industry, regulatory agencies, and patient groups to discuss challenges and opportunities to improve dose selection for patients.