Change Healthcare, a healthcare technology company that is a business unit of Optum and owned by UnitedHealth Group, fell victim to a cyberattack on February 21, 2024. Regular updates on the situation are available for impacted customers on Optum’s website. The American Society of Clinical Oncology (ASCO) is assessing the oncology-specific impact of the attack and will keep its members up to date.

On April 26, 2024, the Food and Drug Administration issued three draft guidance documents on eligibility criteria in cancer clinical trials to address performance status, washout periods and concomitant medications, and laboratory values.
These guidances are a continuation of an effort initiated in 2017 in collaboration with the American Society of Clinical Oncology and Friends of Cancer Research to broaden eligibility criteria in cancer trials. The new guidances provide FDAs current thinking on several critical eligibility categories. 

On April 23, 2024, the Food and Drug Administration granted accelerated approval to tovorafenib (Ojemda, Day One Biopharmaceuticals, Inc.) for patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

On April 18, 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

State governments are increasingly considering legislation to streamline prior authorizations processes, which Association for Clinical Oncology (ASCO) members say delay patient care, adversely affect cancer care outcomes, and divert providers from patient care. States have regulatory authority over fully insured health benefit plans (group and individual plans) and health benefit plans administered by the state itself (Medicaid and state employee benefit plans). This means that state governments can impact plan design through either legislation or regulatory action, and during the past decade, a majority of states have been working to leverage that impact to reform prior authorization.

Today the Department of Health and Human Services (HHS), Department of Labor and the Treasury Department finalized a rule regulating the availability of short-term limited duration insurance (STLDI) plans. The rule would restrict the availability of these plans to no more than four months.

On March 21, 2024, the Food and Drug Administration approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence (OCE).