Since the late 1990s, U.S. Congress has made a concerted effort to increase federal funding for the National Institutes of Health’s (NIH’s) biomedical research and clinical trials. Through rare but always bipartisan largess, legislative appropriators have seen the benefits of investing in the science for precision medicine; supporting genetic-grounded, patient-centered care; and changing the quality and longevity of life for millions of people, including those with cancer diagnoses.
On November 10, 2022, the U.S. Food and Drug Administration (FDA) approved brentuximab vedotin (Adcetris®) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged two years and older with previously untreated, high-risk classical Hodgkin lymphoma. This is the first pediatric approval for brentuximab vedotin.
On November 14, 2022, the U.S. Food and Drug Administration granted accelerated approval to mirvetuximab soravtansine-gynx (Elahere®) for adult patients with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, as detected with an FDA-approved test, who received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx is a FR alpha–directed antibody and microtubule inhibitor conjugate.
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunctions against six e-cigarette manufacturers in October 2022. It was the first time FDA initiated injunction proceedings to enforce review requirements for new tobacco products.
Biomarker- and molecular-driven technologies such as molecular models can precisely predict how an individual’s cancer will respond to certain treatments, the pinnacle of precision oncology. However, established modeling systems such as patient-derived xenografts and patient-derived organoids require large tissue samples and take months or even a year to obtain results, barriers that have limited their application in regular practice.
Making history as the single largest Navigator organization funding award provided to date, the U.S. Department of Health and Human Services, through the Centers for Medicare and Medicaid Services, invested $98.9 million in grant funding to 59 Navigator organizations in August 2022 to help consumers navigate enrollment and make health coverage more accessible.
Growing evidence suggests that the gut microbiome, a diverse and complex mix of microorganisms and their metabolites, is closely linked to the immune system, and researchers are studying whether modulating the gut microbiome affects cancer immunotherapy treatment outcomes. In particular, probiotics—which are flora typically obtained through dietary sources such as yogurt and fermented foods or via supplemental forms—are gaining prominence as a potential strategy to modulate the gut microbiome during cancer treatment.
To better reflect product descriptions and enforce commitment to diversity and inclusion, the U.S. Food and Drug Administration’s Center for Tobacco Products updated its term “grandfathered tobacco product” to “pre-existing tobacco product” in August 2022.
On November 10, 2022, the U.S. Food and Drug Administration approved tremelimumab (Imjudo®) in combination with durvalumab (Imfinzi®) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing epidermal growth factor receptor (EGFR) variant or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
In June 2021, I was at a crossroads in my career. I had been an oncology nurse practitioner for the past 14 years, and it was time to decide if I should retire as a provider. Yet I felt like I still had more to do and more patients to help. I was determined to make a difference for patients with cancer.