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ClinicalTrials & Tribulations
There is general agreement that the United States spends too much on health care, especially on pharmaceuticals. But what we spend on drugs is not simply a function of price. If eggs double in price, people can simply cut the number of eggs they eat in half. Simply stated, cost is the product of (price per unit times the number of units purchased).
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.
FreeGuest Editorial
The ever-rising cost of oncology drugs is doing damage to cancer care on many levels.
ClinicalFreeTrials & Tribulations
Ibrutinib is a selective and irreversible inhibitor of Bruton's tyrosine kinase (BTK) that entered phase 1 clinical trials in 2009 based on preclinical efficacy in models of B-cell malignancy and autoimmune disease.[1, 2] The initial phase 1 trial showed clear efficacy in a number of lymphoid malignancies at doses as low as 1.25 mg/kg/d. Furthermore, full receptor occupancy was demonstrated at 2.5 mg/kg/d. Despite these pharmacological and early clinical findings, development of ibrutinib continued at doses of 420 mg qd and 560 mg qd, levels 3-4 fold higher than suggested by the pharmacological data. In addition, the absorption of ibrutinib is enhanced by administration of food, which may explain why even the lowest dose showed efficacy in some patients.
