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ClinicalFreeTrials & Tribulations
The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June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).
Guest Editorial
On May 28, 2021, the FDA granted an accelerated approval for sotorasib (which had previously received Breakthrough designation) for previously treated KRAS G12C non-small cell lung cancer (NSCLC) at a dose of 960 mg daily.
Guest Editorial
“We are going to start making this a requirement”, stated Richard Pazdur, MD during STAT’s ASCO Recap on June 9, 2021.
COVID-19 & CancerFreeGuest Editorial
The global pandemic of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has led to expectations of global deaths numbering in the hundreds of thousands. Promising therapeutic strategies have emerged slower than society would prefer. COVID-related deaths in the United States exceed 86,000 as of this writing, with projections as high as 134,000.
