The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June 2021, when FDA announced in its accelerated approval of the KRASG12C inhibitor sotorasib that it would require a randomized, controlled trial comparing the efficacy of the labeled dose (960 mg once daily) to a 75% lower dose (240 mg once daily) as a condition of full regulatory approval (The Cancer Letter, June 11, 2021; April 29, 2022).
The American Cancer Society’s Cancer Facts & Figures 2023, released last week, reports that the five-year survival rate for pancreatic cancer is now 12%, an increase of one percentage point from last year.
Technological advances are transforming our understanding of cancer, accelerating the evolution of new treatment approaches. In the past decades, researchers deploying new techniques for analyzing DNA have extended our knowledge of inherited genetic abnormalities that can predispose a person to develop colorectal and other cancers.
We live in an era of quality monitoring—from the quality of products, like water or refrigerators, to the quality of customer service received from repair technicians, food delivery services, and even customer service representatives. This drive for quality measurement has naturally spread into the world of medicine.
For the past several years, interest in FLASH radiation therapy research has surged in the oncology community.1 It is arguably one of the hottest topics in cancer care today, with the potential to shift the trajectory of treatment in ways that were once only imaginable.
Before the results of the ANal Cancer/HSIL Outcomes Research (ANCHOR) study became available earlier this week, there was no clear reason to screen for the anal cancer precursor, anal high-grade squamous intraepithelial lesions (HSIL).
We wish to applaud the sentiments expressed in the recent article in The Cancer Letter titled “Oncologists, advocates, FDA call for an end to MTD and ‘more is better’ era in cancer drug dosing,” but also raise several concerns to be addressed as this initiative moves forward.
As a community, we strive for cancer treatment and research that is data-driven, patient-centered, and that meets the highest standards of quality and safety. Yet, as physicians and advocates, we’ve become aware of a situation where these ambitions are not being met.
Since COVID-19 made its way to the United States, we have seen a stream of worrying news of the pandemic’s impact on cancer care in the U.S., including 9.4 million missed screenings for just about all forms of cancer. While screening rates rebounded in the fall of 2020, there’s a growing concern from oncologists that screenings haven’t returned to pre-pandemic levels for everyone.
The Omicron variant of SARS-CoV-2 is a powerful reminder that the COVID-19 pandemic, now entering its third year, will continue to have personal and public health impacts. This may be especially true for those individuals who unfortunately missed or delayed cancer screening or treatment as a result of the pandemic.
