FDA’s partial recognition ‘credentials our knowledge base as providing accurate, reliable, and clinically meaningful information to the medical and scientific communities,’ notes OncoKB lead scientist
In a precision medicine first, the US Food and Drug Administration (FDA) recently announced “partial recognition” of OncoKB, Memorial Sloan Kettering (MSK) Cancer Center’s oncology knowledge database. Hospital leaders and healthcare providers often encounter difficulties in determining which genomic data sets are reliable and can be used as a basis for clinical decisions. Clinicians who want to leverage the benefits of precision medicine will be pleased that another barrier to personalized medicine has been lifted.
The FDA in its decision summary wrote, “MSK submitted information to support the recognition of the “FDA-Recognized Content” portion of the OncoKB database which lists tumor type-specific somatic alterations and the corresponding FDA level of evidence. This evaluation was based upon whether OncoKB demonstrated conformance with the recommendations described in the FDA’s guidance document. …
“Based upon the information evaluated, the FDA determined that OncoKB conforms to the recommendations described in the guidance supporting the recognition of the OncoKB FDA-Recognized Content portion of the database. … Therefore, FDA recognizes the ‘FDA-Recognized Content’ tab within the OncoKB database. This recognition is expected to provide test developers the opportunity to leverage the OncoKB database to support the FDA’s regulatory review of a submission for a tumor profiling test and other similar somatic genotyping tests seeking authorization,” further states the FDA’s decision summary.
An ‘Expertly Curated Database’ of Cancer-Associated Mutations
MSK initially launched OncoKB in 2016 and has expanded it to include data from most advanced cancer patients treated by MSK.
“Today, tumor genomic profiling is performed for almost every MSK patient with advanced cancer to ensure that we administer the cancer therapy most likely to be effective for that person,” said David B. Solit, MD, director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology at MSK in an MSK press release.
“Each tumor profiled is likely to have several mutations, and it can be challenging for clinicians to memorize which mutations are predictive of response to FDA-approved and experimental therapies or are important for understanding a patient’s prognosis or cancer subtype,” he continued. “OncoKB solves this dilemma by providing an expertly curated database of the biologic and clinical implications of thousands of cancer-associated mutations.”
OncoKB’s database curates genetic information based on three seemingly simple questions that are quite difficult to answer:
- What is the gene being tested?
- Is the mutation in that gene oncogenic (cancer causing)?
- When found with a specific tumor type, what are the therapeutic implications?
By answering these three questions, OncoKB can provide valuable clinical information that enables hospital and oncology leaders to provide more precise personalized medicine treatments.
OncoKB’s curation of its data is further refined based on the answers to the three core questions for each genetic mutation. It organizes the data into four different levels that indicate clinical reliability:
- Level One: The referenced mutation is recognized by the FDA as a biomarker for an FDA-approved treatment.
- Level Two: The referenced mutation is widely recognized as a “standard-of-care” biomarker that can indicate the need for an FDA-approved treatment.
- Levels Three and Four: There is clinical and/or biological evidence that a treatment works for a mutation, but that treatment is still being studied.
Level one and level two genes generally can be used by hospitals and oncologists to prescribe precision medicine treatments, while level three and level four genes may be better used in precision medicine clinical trials.
OncoKB First Somatic Cancer Database to Gain FDA Recognition
In an interview with Medscape Medical News, OncoKB lead scientist and an assistant attending physician in Memorial Sloan Kettering’s Department of Pathology, Debyani Chakravarty, PhD, acknowledged that OncoKB is not the only database of its kind. “But that being said, it is now the first somatic human cancer variant database to be recognized by the FDA,” she said, emphasizing the value that the FDA’s partial recognition status adds for clinicians looking for reliable precision medicine information.
“What sets OncoKB apart is its active curation by disease experts and scientists at MSK who are at the forefront of cancer treatment and research,” Chakravarty said. “With the FDA partial recognition of OncoKB, the agency credentials our knowledge base as providing accurate, reliable, and clinically meaningful information to the medical and scientific communities.”
Hospital and oncology leaders will greatly benefit from being aware that there is now an oncological precision medicine database that can be used to identify personalized cancer treatments quickly and easily. The unique curation method used by OncoKB, coupled with its recent FDA recognition, make it a reliable tool to provide actionable precision medicine insights that could be immediately employed in clinical settings.
—Caleb Williams
Related Information:
A Milestone for Precision Oncology: FDA Gives Green Light to MSK’s Genetic Database
FDA: Genetic Database Recognition Decision Summary for OncoKB