Abstract
A collection of recently published news items.
The FDA authorized a third dose of the Pfizer/BioNTech and Moderna COVID-19 vaccines for people who are moderately to severely immunocompromised due to their greater risk of developing severe COVID-19 infections. According to the Centers for Disease Control and Prevention, this group includes patients receiving active treatment for solid or hematologic malignancies.
In addition, the agency denied marketing applications for more than 55,000 flavored electronic-cigarette products submitted by three companies. The FDA claimed that there isn't enough evidence that the items help adult smokers of combustible cigarettes to quit to outweigh the risk of widespread use among children. In total, more than 500 companies submitted applications for more than 6.5 million new tobacco products ahead of the September 9, 2020, deadline.
Researchers reported that Merck's pembrolizumab (Keytruda) may be an effective adjuvant therapy for patients with clear-cell renal-cell carcinoma and a high risk of recurrence after nephrectomy (N Engl J Med 2021;385:683–94). In the phase III KEYNOTE-564 trial, patients treated with the PD-1 inhibitor had a 24-month disease-free survival rate of 77.3%, compared with 68.1% in those who received a placebo.
BeyondSpring's investigational agent plinabulin plus docetaxel may have activity in patients with non–small cell lung cancer who have received other therapies. In the phase III DUBLIN-3 trial, patients treated with the combination had a 24-month overall survival rate of 22.1%, compared with 12.5% in patients who received docetaxel alone. Plinabulin is a selective immunomodulating microtubule-binding agent that stimulates antigen-presenting cells.
The quality of real-world data (RWD) for novel cancer drugs may be lacking (Eur J Cancer 2021;6:136–44). Researchers analyzed 293 RWD studies for 45 drugs approved by the FDA and the European Medicines Agency between 2010 and 2015 to treat solid tumors. They found that 78% of RWD studies were classified as low quality, and the differences in median survival between the RWD studies and the corresponding clinical trials range from -32 months to 21 months.
For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.
