A collection of recently published news items.
The FDA approved the selective TRK inhibitor entrectinib (Rozlytrek; Genentech) in adults with ROS1-positive, metastatic non–small cell lung cancer. The agency also granted the drug an accelerated approval in adults and children ages 12 and older with NTRK-positive solid tumors whose cancer has progressed on other therapies, or who lack first-line treatment options. The approvals were based on four trials in which the therapy elicited high overall response rates and durable responses.
Medicare will begin covering chimeric antigen receptor T-cell therapies per a final rule issued by the Centers for Medicare & Medicaid Services (CMS; https://www.cms.gov/medicare-coverage-database/). The coverage, which extends to FDA-approved therapies as well as CMS-approved off-label uses, includes tisagenlecleucel (Kymriah; Novartis) and axicabtagene ciloleucel (Yescarta; Gilead) for certain leukemias and lymphomas.
Preliminary results suggest that AstraZeneca's experimental WEE1 inhibitor adavosertib (AZD1775) may be a promising first-line treatment for pancreatic cancer (J Clin Oncol 2019 August 9 [Epub ahead of print]). In a phase I trial, patients treated with the drug in combination with gemcitabine and radiation had a median overall survival of 21.7 months and a median progression-free survival of 9.4 months.
Celgene will pay Immatics $75 million up front to jointly develop three adoptive cell therapies for cancer—and up to $505 million more in milestone payments for each therapy. As part of the deal, Immatics will handle the initial development and validation of the therapies, at which point Celgene will have the option to take over development, manufacturing, and commercialization.
Globally, 11.5 million years of healthy life were lost in 2017 due to childhood cancer, according to a study based on the Global Burden of Diseases, Injuries, and Risk Factors Study of 2017 (Lancet Oncol 2019;20:1211–25). Researchers also found that childhood cancer was the sixth leading cause of cancer burden and the ninth leading cause of childhood diseases, disorders, illnesses, and infections.
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