ESMO discussants urge physicians to prescribe lower dose of Amgen’s sotorasib

Sen. Durbin weighs in on the controversy about dosage of Amgen drug sotorasib

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.

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

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.

December 15, 2023

Vol.49 No.46

By Matthew Bin Han Ong

Regulatory News

ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials

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.

October 06, 2023

Vol.49 No.37

By Jacquelyn Cobb and Paul Goldberg

Guest Editorial

What’s the right dose of sotorasib? Is it 240 mg qd or 4x that?
The Oct. 5 ODAC will be a nailbiter

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.

ASCO receives $11M from PCORI to study oral drug dosing strategies

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.

July 21, 2023

Vol.49 No.29

Clinical

In the era of immunotherapy and targeted therapies, ODAC focuses on dose optimization in children

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.

June 23, 2023

Vol.49 No.25

By Jacquelyn Cobb

ESMO discussants urge physicians to prescribe lower dose of Amgen’s sotorasib

YOU MAY BE INTERESTED IN

Sen. Durbin weighs in on the controversy about dosage of Amgen drug sotorasib

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials

What’s the right dose of sotorasib? Is it 240 mg qd or 4x that?
The Oct. 5 ODAC will be a nailbiter

ASCO receives $11M from PCORI to study oral drug dosing strategies

In the era of immunotherapy and targeted therapies, ODAC focuses on dose optimization in children

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ESMO discussants urge physicians to prescribe lower dose of Amgen’s sotorasib

YOU MAY BE INTERESTED IN

Sen. Durbin weighs in on the controversy about dosage of Amgen drug sotorasib

FDA, Friends identify next steps for dose optimization, pragmatic trials, academic-led studies for drug approvals

ODAC vote on sotorasib signals FDA intent to confront perceived loss of equipoise in cancer clinical trials

What’s the right dose of sotorasib? Is it 240 mg qd or 4x that?The Oct. 5 ODAC will be a nailbiter

ASCO receives $11M from PCORI to study oral drug dosing strategies

In the era of immunotherapy and targeted therapies, ODAC focuses on dose optimization in children

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What’s the right dose of sotorasib? Is it 240 mg qd or 4x that?
The Oct. 5 ODAC will be a nailbiter