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.
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.
On Oct. 5, the FDA Oncologic Drugs Advisory Committee will meet to consider full approval of the supplemental new drug application for Amgen’s agent Lumakras (sotorasib), based on the CodeBreak 200 study.
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.