Joint Position Statement: Therapeutic Group Labeling Will Improve Access, Simplify Clinical Practices, Enhance Diagnostic Efficiency
April 25, 2024
The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) are calling on manufacturers of diagnostics and therapeutics to adopt therapeutic group labeling to improve access to effective modern therapies for patients, according to a joint position statement published April 25, 2024.
Therapeutic group labeling also will enhance clinical decisions, diagnostic efficiency, and cost effectiveness, the two organizations said.
"The traditional ‘one-drug/one-test’ approach to in vitro companion diagnostics can be harmful to patients because it limits their access to some of the most effective therapeutics available,” said ASCO Chief Medical Officer Julie Gralow, MD, FACP, FASCO. “With this position statement, ASCO and CAP are hopeful that manufacturers of diagnostics and therapeutics will adopt therapeutic group labeling to improve access to effective modern therapies for all."
In cancer treatment, drugs and biologic therapies are often used to target a molecular aspect, or biomarker, of a cancer cell or person’s immune response. However, before these therapies can be used, a diagnostic test is performed to determine whether the patient’s tumor is likely to respond.
To provide access to appropriate therapies, oncologists and pathologists must perform multiple tests that target a patient’s tumor.
“For patients, this may result in additional time to complete their evaluation and diagnosis, as well as additional expenses,” said CAP President Donald Karcher, MD, FCAP. “The CAP and ASCO believe therapeutic group labeling will enhance patient access, clinical simplicity, diagnostic efficiency, and cost effectiveness for these important therapies.”
Support for Regulatory Pathway Detailed in FDA Guidance
During clinical trials, therapeutic manufacturers often use one or more devices/tests and usually submit a single device/test to the U.S. Food and Drug Administration (FDA) if the diagnostic requires the agency’s clearance for approval. This can pose challenges to achieving equitable biomarker-driven care such as delays, increased costs, and confusion for clinicians and patients alike.
Because a large amount of evidence is required to support a companion diagnostic claim, companies are not incentivized to collaborate or share data and peer-reviewed evidence and publicly available data are insufficient as a result. This leads to oncologists and pathologists being challenged to remain up-to-date, particularly when a new diagnostic is required for a particular biomarker/therapeutic pairing, according to the statement.
The two organizations noted that the FDA has recognized the challenges associated with its testing process. In 2020 the agency published a guidance that enables manufacturers to seek a diagnostic label for a group of therapeutics (e.g., anti-PDL1 or EGFR inhibitors) that aligns diagnostic labeling with therapeutic labeling, enabling a diagnostic label to refer to a group of therapies, not only the specific therapeutic it was paired with at approval, but adoption has been slow. According to the FDA, only four companion diagnostics have received group labeling claims as of October 5, 2023.
ASCO and CAP support use of the regulatory pathway recommended in the FDA guidance with the following recommendations for manufacturers:
• Prioritize evidence development through decentralized trial elements to support labeling diagnostics for use in a group of oncology therapeutics, rather than labeling a companion diagnostic for a single therapeutic product within the group.
• Explore extending diagnostic labels for existing companion diagnostics to a therapeutic group of products through submission of a supplemental application. To do this, they suggested manufacturers work with the FDA to implement innovative approaches to evidence generation and regulatory flexibility.
• Prioritize broadening labels of the diagnostics that guide the use of PD-(L)1 directed immune checkpoint inhibitor (ICI) therapeutics.
“ASCO and CAP believe therapeutic group labeling will enhance patient access, clinical simplicity, diagnostic efficiency, and cost effectiveness for these important therapies,” the statement concluded.
Read the full statement.
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