Abstract
A collection of recently published news items.
The FDA approved the PARP inhibitor niraparib (Zejula; Tesaro) for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with at least three chemotherapies and whose tumors are positive for homologous recombination deficiency. The decision was based on the phase II QUADRA trial in which patients had an overall response rate of 24%.
Bristol-Myers Squibb's PD-1 inhibitor nivolumab (Opdivo) and its CTLA4 inhibitor ipilimumab (Yervoy) could be a new first-line treatment for advanced non–small cell lung cancer. In the CheckMate-227 trial, the combination extended median overall survival compared with chemotherapy, regardless of PD-L1 level. Results were presented at the ESMO Congress 2019 in Barcelona, Spain, and concurrently published (N Engl J Med 2019 Sep 28 [Epub ahead of print]).
GRAIL released data validating its multicancer early-detection test that analyzes cell-free DNA in blood samples. The company ran its test on 1,264 participants, including 654 people with cancer. With 99.3% specificity, the test had an overall detection rate of 76% for 12 cancers that generally have a poor prognosis.
Multiple organizations, including the American Cancer Society, published guidelines outlining how exercise can reduce the risk of developing cancer and improve the prognosis for people with cancer (CA Cancer J Clin 2019 Oct 16 [Epub ahead of print]). The guidelines suggest that physically active people could reduce their risk of certain cancers by up to 69% compared with those who are sedentary, and exercise during or after cancer treatment is associated with longer life and improved mood and energy levels.
At the Biopharma Congress in Washington, DC, FDA leaders expressed concern about the agency's ability to recruit and retain experts in cutting-edge scientific fields such as cell and gene therapies and oncology. “We're dealing with the issue of a very competitive job market,” said Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Review.
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