Noted This Week

January 4–10

Eli Lilly announced it will acquire Loxo Oncology for $8 billion. With the deal, Lilly will gain access to Loxo’s cancer drugs—including the TRK inhibitor larotrectinib (Vitrakvi), which was approved in November for patients with solid tumors harboring NTRK1/2/3 fusions, and the RET inhibitor LOXO-292, which is being tested in various solid tumors, including lung and thyroid cancers.

As the partial government shutdown continues, the FDA announced it will shift funds to prioritize drug safety surveillance over premarket drug review. Since the start of the shutdown, the FDA has recalled several drugs due to safety concerns, including an anesthesia companion injection and a blood pressure medication. Currently, about 40% of FDA employees are furloughed.

Artificial intelligence may identify cervical cancer and precancer, according to findings published in the Journal of the National Cancer Institute. Researchers developed and trained a deep-learning algorithm using more than 60,000 photos from cervical cancer screenings. They found that the algorithm was significantly more accurate than clinicians or conventional cytology at identifying cases of cervical cancer and precancer, achieving an area under curve of 0.91, compared with 0.69 and 0.71, respectively.

The BRCA Exchange, a large-scale database of information on BRCA genes, became publicly available. The database, which was created through the BRCA Challenge, contains more than 20,000 unique BRCA1 and BRCA2 variants, including 6,100 variants that have been classified by an expert panel and 3,700 that are known to cause disease. A paper describing the development of the database was published in PLOS Genetics.

The U.S. cancer death rate has decreased continuously for the past 25 years, according to a report published by the American Cancer Society. Overall, the cancer death rate dropped by 27% between 1991 and 2016, although cancer is still the second leading cause of death after heart disease. The report also estimates that there will be 1,762,450 new cancer cases and 606,880 cancer deaths in the United States in 2019.

At the JP Morgan Healthcare Conference in San Francisco, CA, Exact Sciences announced that sales of its Cologuard test had a 115% compound annual growth rate between 2014 and 2018, but the test has been adopted by only 4% of its potential market. Cologuard, which was FDA approved in 2014, is a diagnostic test for colon cancer that detects DNA markers shed by cancerous and precancerous cells in a patient’s stool. In late 2018, Exact Sciences made a deal with Pfizer to jointly promote the test through 2021.

Also at the JP Morgan Healthcare Conference, UroGen Pharma announced positive results from a phase III trial of UGN-101, a novel version of the chemotherapeutic mitomycin. In the OLYMPUS trial, UGN-101 elicited complete responses (CR) in 57% of 61 patients with low-grade upper-tract urothelial carcinoma, and all evaluable patients with a CR were disease free at 6 months.

A patient with glioblastoma was the first to receive treatment under “right to try” legislation. The patient, who failed to qualify for a clinical trial, was treated with the experimental immunotherapeutic vaccine ERC-1671 (ERC-USA) after ERC-USA informed the FDA that it would provide the therapy. Passed last year, the legislation allows terminally ill patients to seek experimental treatments directly from pharmaceutical companies, outside of the FDA’s expanded access pathway.


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