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Noted This Week

September 16–22

The FDA granted accelerated approval to selpercatinib (Retevmo; Eli Lilly) to treat adults with locally advanced or metastatic solid tumors with a RET gene fusion whose cancer has advanced on or after a systemic treatment or who have no other satisfactory therapeutic options. Data from the LIBRETTO-001 trial showed that selpercatinib yielded clinically meaningful and durable responses across a variety of tumor types, including pancreatic and colon cancers, in patients with RET-driven malignancies. The agency also granted regular approval to selpercatinib for the treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a RET gene fusion; the drug had received accelerated approval for this indication in 2020.

By a 9–4 vote, an FDA advisory committee decided that the possible benefits of poziotinib do not outweigh the risks for patients with NSCLC with HER2 exon 20 insertion mutations, MedPage Today reported. The committee said that the Spectrum Pharmaceuticals drug, a tyrosine kinase inhibitor, did not demonstrate a major improvement over other treatment options and produced high rates of toxicity that required dose interruptions or reductions; it also said that Spectrum didn’t sufficiently examine various doses, a claim that the company denied. When considering drugs for approval, the FDA need not follow its advisory committee’s advice but it usually does so.

Fennec Pharmaceuticals announced that the FDA approved sodium thiosulfate (Pedmark) to reduce the risk of hearing loss associated with cisplatin in children aged 1 month or older with localized non-metastatic solid tumors. The approval was based on safety and efficacy data from two pivotal randomized phase III trials that compared sodium thiosulfate plus cisplatin with cisplatin alone. In both studies, the incidence of hearing loss was significantly lower in the sodium thiosulfate arm.

The American Association for Cancer Research (AACR) released its 12th annual Cancer Progress Report, which provides “up-to-date cancer incidence, mortality, and survivorship statistics and discusses the latest research in cancer etiology, biology, early detection, diagnosis, treatment, and prevention, including the use of artificial intelligence (AI)-based early detection systems and liquid biopsies that are moving rapidly to the clinic” (https://cancerprogressreport.aacr.org). It also makes policy recommendations to make sure that the United States “maintains its momentum against cancer.”

The AACR celebrated its 115th anniversary. At a gala event in Washington, DC, the nonprofit also bestowed awards on numerous individuals and organizations for their outstanding efforts to advance cancer research.

Additional news from September 9–15:

On the 60th anniversary of President John F. Kennedy’s “Moonshot” speech, President Joe Biden outlined several research advances against cancer that have occurred as part of his reinvigorated Cancer Moonshot effort. Among them: an executive order to establish the Biotechnology and Biomanufacturing Initiative to ensure that cutting-edge technologies and other innovations are developed and manufactured in the United States, a cap on out-of-pocket prescription drug costs for Medicare beneficiaries that could save patients with cancer thousands of dollars a year, and the launch of a large national trial to identify and develop blood tests to detect cancer.

Biden appointed Renee Wegrzyn, PhD, as the first director of the Advanced Research Projects Agency for Health (ARPA-H), which was created in 2020 to drive biomedical innovation and medical research to “prevent, detect, and treat some of the most intractable diseases, including cancer,” according to a White House press release. Wegrzyn is currently a vice president of business development at Ginkgo Bioworks and head of innovation at Concentric by Ginkgo. She previously served as program manager in the Biotechnologies Office of the Defense Advanced Research Projects Agency, one of the institutions that inspired the creation of ARPA-H.

The Oversight Committee of the Cancer Prevention and Research Institute of Texas (CPRIT) approved $49 million in research grants to support core facilities, access to clinical trials, computational oncology, drug discovery, and childhood cancer research. CPRIT, created and approved by voters in the state in 2007, is the largest state funder of cancer research and the second largest source of public funding for cancer research in the world.

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