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Noted This Week

February 23–29

On February 29, the U.S. Congress passed a stopgap measure to keep a tranche of federal offices running for another week. Funding for the FDA, the Department of Agriculture, and many other departments and agencies was set to run out at midnight tonight, but the deadline to finalize the fiscal year 2024 budget for these groups has been extended to March 8. Lawmakers have until March 22 to wrap up the budget for the balance of federal departments and agencies—including the NIH, NCI and the Centers for Disease Control and Prevention. Until then, all federal operations will continue their activities at fiscal year 2023 spending levels.

The President’s Cancer Panel issued its first report on progress toward meeting the goals outlined in the National Cancer Plan (https://nationalcancerplan.cancer.gov), which was released last year under the leadership of then–NCI Director Monica Bertagnolli, MD, and its “recommendations for changes that can make a difference right now” (https://prescancerpanel.cancer.gov/pdfs/CancerPanelReport.pdf). For example, the group says Medicare and Medicaid should “cover all telehealth services and encourage all health plan providers to do the same.” Also, to advance cancer research and workforce development, they wrote that “it is imperative that both Congress and private sector organizations—biopharmaceutical companies in particular—intensify their investments in these areas.” The panel is a federal advisory committee charged with monitoring the National Cancer Program and reporting any barriers to its execution, as well as its successes, to the president.

Stockholm, Sweden–based Oncopeptides announced that the FDA will withdraw its accelerated approval of melphalan flufenamide (Pepaxto), which had been greenlighted in combination with dexamethasone to treat adults with relapsed/refractory multiple myeloma who had already received at least four other therapies in 2021. Oncopeptides was required to conduct the post-approval OCEAN trial to confirm a benefit to patients. However, in reviewing the data, the FDA concluded that the agent offered no clinical benefit and was not shown to be safe or effective.

An injectable form of Xgeva (denosumab; Amgen) was the first product in the UK to be authorized by the Medicines and Healthcare Products Regulatory Agency (MHRA) through the new International Recognition Procedure (IRP). Launched in January following the UK’s exit from the European Union (EU), the IRP replaces the European Commission for assessing drugs and allows the MHRA to take the expertise and approval decisions from regulatory agencies in Australia, Canada, the EU, Japan, Singapore, Switzerland, and the United States into consideration when making approval decisions on the same product; doing so will mean fewer delays in getting medications to patients, regulators say. Denosumab is used to treat serious bone-related complications caused by tumor metastasis.

In a population-based cross-sectional analysis of data reported to the US Cancer Statistics from January 1, 2018, to December 31, 2020, found that observed rates of all types of cancer were 28.6% lower than anticipated during the height of the COVID-19 pandemic (March through May 2020) compared with pre-pandemic trends (JAMA Oncol 2024 Feb 22 [Epub ahead of print]). Between June and December 2020, rates were 6.3% lower; overall, the rate was 13% lower. Based on 1,297,874 cancer cases reported between March 1 and December 31, 2020, researchers calculated that approximately 134,395 cancers went undiagnosed during that timeframe.

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