Sen. Richard J. Durbin (D-IL) has asked Amgen to provide copies of the company’s communications with FDA related to the dosage of Lumakras (sotorasib), a KRAS inhibitor marketed under an accelerated approval for non-small cell lung cancer.
To improve evidence generation in studies designed to bring therapeutic agents to market, FDA is urging drug sponsors not to skip dose optimization at the outset of clinical development. The agency is also telling industry that it’s open to accepting trials that have pragmatic elements and are augmented by data generated in academia.
Experts in pharmacology and lung cancer urged physicians to prescribe the Amgen agent Lumakras (sotorasib) at the lowest tested dose—240 mg—instead of the four times higher dose of 960 mg recommended by the sponsor.
The FDA Oncologic Drugs Advisory Committee concurred with the FDA staff that the Amgen Inc. confirmatory trial of the lung cancer therapy sotorasib (Lumakras) was uninterpretable as a result of a perceived loss of equipoise.
The American Society of Clinical Oncology was awarded $11 million in research funding by the Patient-Centered Outcomes Research Institute to study dosing strategies of oral CDK4/6 inhibitors in older adults living with metastatic breast cancer.
Setting cancer drug dosage used to be easy: find the delicate balance between killing the disease and subjecting the patient to intolerable harm, and you are done.