Noted This Week

June 15–21

Tabelecleucel (Tab-cel; Atara), an off-the-shelf T-cell therapy, may improve survival for patients with Epstein–Barr virus–associated post-transplant lymphoproliferative disorder, according to findings reported at the 23rd Congress of the European Hematology Association in Stockholm, Sweden. In a phase II trial, patients who developed the disorder following hematopoietic cell transplant and subsequently received the therapy had an overall response rate (ORR) of 69% and overall survival (OS) rates of 68% at 1 year and 55% at 3 years. In another phase II trial, patients who were treated following solid organ transplant had an ORR of 50% and OS rates of 64% at 1 year and 43% at 3 years.

The FDA restricted the use of pembrolizumab (Keytruda; Merck) and atezolizumab (Tecentriq; Genentech) in patients with advanced urothelial cancer: Now, patients who are not eligible for cisplatin-containing therapy can be treated with the drugs only if they have PD-L1 expression above 10% or 5%, respectively. Patients not eligible for any platinum-containing therapy can still receive the checkpoint inhibitors, regardless of PD-L1 expression.

The FDA withdrew a draft guidance on the development of biosimilars issued in September 2017. The guidance was designed to help companies evaluate proposed biosimilars in comparison to existing products. "One of the central aspects of biosimilar development and approval is the analytical studies performed to demonstrate that a biosimilar is highly similar to the reference product," said FDA Director Scott Gottlieb, MD. "We're taking a fresh look at our draft recommendations for evaluating analytical studies in order to ensure our guidance takes into consideration the most current and relevant science."

Recent-onset type 2 diabetes may be an early sign of pancreatic cancer, according to a study in the Journal of the National Cancer Institute. In a prospective study of 48,995 African Americans and Latinos, researchers identified 15,833 who developed diabetes and 408 who developed pancreatic cancer. In total, 52.3% of patients with pancreatic cancer had recent-onset diabetes, meaning within the 36 months before their cancer diagnosis. Overall, diabetes was associated with an approximately twofold greater risk of pancreatic cancer; the increase was even more pronounced in patients with recent-onset diabetes.

TAS-102, a combination of trifluridine and tipiracil (Lonsurf; Taiho Pharmaceutical) may improve survival in patients with metastatic or advanced gastric cancer who haven't responded to other therapies, according to findings reported at the 2018 World Congress on Gastrointestinal Cancer in Barcelona, Spain. In the phase III TAGS trial, patients treated with the drug had an OS of 5.7 months, compared with 3.6 months in patients who received a placebo. TAS-102 has FDA approval for metastatic colorectal cancer in patients who have already received other therapies.

The Centers for Disease Control and Prevention reported that in 2017, 13.9% of U.S. adults were cigarette smokers—the lowest level ever recorded. In 2009, 20.2% of U.S adults smoked cigarettes.


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