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

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

Clinical Trials & Tribulations

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

The release of FDA’s draft guidance, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” has been greatly anticipated since June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).

January 27, 2023

Vol.49 No.04

By Mark J. Ratain and Garth W. Strohbehn

Drugs & Targets

FDA publishes draft guidance on optimizing dosage for oncology drugs

FDA issued a draft guidance for industry, “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.”

January 20, 2023

Vol.49 No.03

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

YOU MAY BE INTERESTED IN

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

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

FDA publishes draft guidance on optimizing dosage for oncology drugs

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

YOU MAY BE INTERESTED IN

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

Ignore at your own risk: FDA draft guidance puts flashing lights around “dose optimization”

FDA publishes draft guidance on optimizing dosage for oncology drugs

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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