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Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”
FreeTrials & Tribulations

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June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).
C. David Allis, pioneer of chromatin biology and epigenetics, dies at 71
FreeObituary

C. David Allis, pioneer of chromatin biology and epigenetics, dies at 71

When you hear the words “world famous scientist,” “devoted parent and husband,” “enthusiastic mentor,” and “committed friend,” who comes to mind?  I, like many others across the world, think of Dr. C. David Allis. David, a prolific scientist, with over 400 publications and more than 100,000 citations, made many discoveries that have shaped our understanding about how genes are regulated and made a full circle bench-to-bedside impact. 
A New Year’s greeting from Ukraine
FreeGuest Editorial

A New Year’s greeting from Ukraine

The year of 2022 was probably the most challenging and hard for Ukraine since the start of our independence. Our lives have changed significantly as we are fighting for the world’s freedom and democracy. In these circumstances, the Ukrainian healthcare system remained stable and doctors kept doing their job at hospitals around the country, including oncologists who did their best to treat patients in any way possible.
S2302 Pragmatica-Lung Trial: Reaching more representative groups of patients with exciting clinical trials
FreeGuest Editorial

S2302 Pragmatica-Lung Trial: Reaching more representative groups of patients with exciting clinical trials

S2302 Pragmatica-Lung is a federally-funded, streamlined clinical trial examining a new combination of agents in patients with advanced non-small cell lung cancer (NSCLC). Like most studies, it is focused on improving outcomes for patients with cancer—but it is also poised to simplify and transform the entire clinical trials model as we know it.