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BioCentury - Broadening role for external control arms in clinical trials

External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The field is largely split between those drawing on past clinical trials versus real-world data, and at least one company is pushing the approach further by simulating artificial patients to augment control arms in complex, chronic indications like Alzheimer’s disease.

 

The ASCO Post - Accelerated Approval Program: For the Benefit of Patients

A DIAGNOSIS of any life-threatening cancer or other serious illness has always been a world-shaking event for those touched by significant disease, and most of us have known—or will know—the frustration, helplessness, and desperate sense of urgency provoked by the words, “The disease is worsening, and there is no known cure.” After decades of patient advocacy, the U.S. Food and Drug Administration (FDA) acknowledged that urgency by establishing its Accelerated Approval Program in 1992.

BioNews Feed - Keytruda Found to be Safe as Cancer Treatment for HIV Patients, Phase 1 Trial Shows

The immune checkpoint inhibitor Keytruda (pembrolizumab) was found to be a safe treatment for different cancer types among people living with HIV, data from a Phase 1 trial show.

 

The results are likely applicable to other immune checkpoint inhibitors targeting the same pathway as Keytruda, the investigators said.

 

Oncology Times - Advice on Charting an Innovative Path Forward for Cell Therapies

Cellular advances in the field of immunotherapy such as chimeric antigen receptor (CAR) T-cell therapy and tumor-infiltrating lymphocytes are generating great interest in oncology even as scientists, manufacturers, and regulators grapple with the challenges of bringing them to the clinic.

 

Targeted Oncology - FDA Issues Draft Guidance to Broaden Clinical Trial Inclusion

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials.1 The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

 

Pink Sheet - US FDA Seeks Ways To Prevent Non-Responders From Sinking Tissue-Agnostic Indications

Executive Summary

Agency officials and oncologists debate considerations where a data package overwhelms non-responders in favor of a tissue-agnostic indication.


Sponsors may be able to obtain a tissue-agnostic indication despite failing to show a response in one tumor type as the US Food and Drug Administration intends to remain flexible with its approval requirements.

 

Pink Sheet - Tissue-Agnostic Cancer Treatments: Can US FDA-Approved Diagnostics Limit Access?

Executive Summary

ASCO official argues postmarket development of diagnostics may restrict patient use once added to the label.

 

Stakeholders are warning the US Food and Drug Administration that slow companion diagnostic development for new tissue-agnostic cancer treatments may raise concerns about patient access.

 

Pink Sheet - Real-World Evidence Could Become Effective Tissue-Agnostic Carving Knife

Executive Summary

The data may be different, but US FDA will consider real-world evidence to add a tissue-agnostic indication, as well as take it away.


Sponsors may be able to use real-world data to expand an oncology therapy to a tissue-agnostic indication, but a US Food and Drug Administration official warned that the data also could take that indication away.

 

The Washington Examiner - The facts about Biden's sweeping, incautious promise to end cancer

Joe Biden promised last week that if he is elected to the Oval Office, "we're gonna cure cancer."

 

It was definitive in a way that the statement he made as vice president in 2015 — “If I could be anything, I would have wanted to have been the president that ended cancer, because it's possible" — was not.

 

On the one hand, Biden's sweeping promise, which some online critics derided as irresponsibly optimistic, isn't as lofty as it might appear at first glance. Some cancers are already considered curable, and scientists believe they're close to curing others.

Pink Sheet - FDA Signals Willingness To Grant Regulatory Flexibility For Cell and Gene Therapy Products In CMC Reviews

The US Food and Drug Administration is willing to grant regulatory flexibility for manufacturers of cell and gene therapy products from certain chemistry, manufacturing and controls (CMC) requirements in biological license applications. An agency official acknowledged that the difficulties in manufacturing these products demand such flexibility, which will make it easier to move them from the research lab to patients. Yet such flexibility will only be granted on a case-by-case basis.

 

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