A collection of recently published news items.
The FDA approved cabozantinib (Cabometyx; Exelixis) for patients with hepatocellular carcinoma who received prior sorafenib (Nexavar; Bayer/Onyx). Approval was based on a phase III trial in which patients treated with the tyrosine kinase inhibitor (TKI) had a median overall survival of 10.2 months and a median progression-free survival of 5.2 months, compared with 8 months and 1.9 months, respectively, in patients who received a placebo.
The FDA approved 23andMe's direct-to-consumer genetic test for a hereditary colorectal cancer syndrome. The MUTYH-Associated Polyposis Genetic Health Risk report tests for two MUTYH variants that can increase the risk of developing colorectal cancer by 43% to 100%. The FDA previously approved 23andMe's test for three BRCA1/2 mutations.
Patients with comorbidities are less likely to participate in clinical trials (JAMA Oncol 2019 Jan 10 [Epub ahead of print]). Researchers analyzed survey data from 5,499 patients with cancer and found that 37.2% of those with comorbid conditions discussed clinical trials with their clinicians, 15.7% were offered slots, and 7.8% participated, compared with 44.1%, 21.7%, and 11.3% of those without multiple health problems.
The U.S. House of Representatives Committee on Oversight and Reform announced it will investigate the drug-pricing methods of pharmaceutical companies. The committee requested information from 12 companies about 18 drugs, including Celgene's immunomodulatory agent lenalidomide (Revlimid), AbbVie/Johnson & Johnson's Bruton TKI ibrutinib (Imbruvica), and Novartis's TKI imatinib (Gleevec).
Scientists characterized new subtypes of B-cell acute lymphoblastic leukemia (B-ALL; Nat Genet 2019;51:296–307). Researchers performed an integrated genomic analysis on 1,988 cases of pediatric and adult B-ALL and identified 23 subtypes of the disease, including eight new subtypes. Two of the new subtypes have PAX5 alterations and account for 10% of previously uncategorized cases of the disease; a third, defined by a rearrangement of BCL2 with MYC or BCL6, is associated with poor outcomes in patients.
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