Noted This Week
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 (ORR) and durable responses.
The FDA issued a proposed rule that would require graphic health warnings on cigarette packaging and advertisements. The 13 warnings, which fulfill a requirement of the Family Smoking Prevention and Tobacco Control Act, would include photorealistic color images of lesser-known health risks of smoking, such as bladder cancer, diabetes, and erectile dysfunction. The rule is open for public comment until October 15 at https://www.federalregister.gov/.
Preliminary results in the Journal of Clinical Oncology suggest that AstraZeneca’s experimental WEE1 inhibitor adavosertib (AZD1775) may be a promising first-line treatment for pancreatic cancer. In a phase I trial, patients treated with the drug in combination with gemcitabine and radiation had a median overall survival (OS) of 21.7 months and a median progression-free survival (PFS) of 9.4 months. Researchers are planning a phase II trial in pancreatic cancer and testing adavosertib in other solid cancers, including breast and ovarian cancers.
RABL3 mutations increase the risk of hereditary pancreatic ductal adenocarcinoma, according to findings in Nature Genetics. Researchers identified the mutation by performing genomic sequencing on multiple members of the same family who developed pancreatic cancer. They then recreated the mutation in zebrafish to further investigate its mechanism and biological function.
Deciphera announced that the KIT and PDGFRα inhibitor ripretinib (DCC-2618) may be an effective fourth- or fifth-line treatment for advanced gastrointestinal stromal tumors. In the phase III INVICTUS trial, patients treated with ripretinib had a median PFS of 6.3 months, a median OS of 15.1 months, and an ORR of 9.4%, compared with 1 month, 6.6 months, and 0%, respectively, in patients who received a placebo.
The U.S. Court of Appeals for the Federal Circuit upheld Sanofi’s patents on cabazitaxel (Jevtana), a microtubule inhibitor approved for metastatic, hormone-refractory prostate cancer. The decision overturns a previous ruling by the U.S. District Court of New Jersey that deemed one of Sanofi’s patents invalid. The lawsuit began after drug companies applied to the FDA to make generic versions of the drug before its patents expire in 2031, prompting Sanofi to sue.
Healthcare company Synapse and the FDA Oncology Center for Excellence announced a multiyear collaboration on real-world evidence (RWE) to support regulatory decisions. The organizations will explore methods of gathering RWE from electronic health records and other sources, and will investigate the utility of real-world endpoints in oncology trials.
Black and Hispanic patients are underrepresented in clinical trials that lead to oncology drug approvals, according to a study in JAMA Oncology. Researchers analyzed 230 trials conducted between 2008 and 2018 and found that 3.1% of participants were black and 6.1% were Hispanic—22% and 44%, respectively, of the expected proportions. Overall, 63% of trials reported on at least one race, and just 7.8% documented the four major U.S. races (white, Asian, black, and Hispanic).