A new article from BioQuick News discusses Cancer Commons founder Marty Tenenbaum’s presentation at last week’s Personalized Medicine World Conference:
In the PMWC 2017 discussion, Dr. Tenenbaum focused on the question: When faced with certain death, is it acceptable to accept less than 100% proven safety and efficacy? Patients with glioblastoma and certain other cancers with dire prognoses do not have the time to wait for new treatments to be fully approved by the FDA. Is it time to add ‘conditional approval’ as an additional pathway to approval for these patients? In the session, he described a plan that will be proposed by which the FDA could “conditionally approve” a treatment that has been proven safe in a clinical trial(s) with at least 25 patients, and has demonstrated biologic activity. Therefore, this treatment could not be denied by insurance as being “experimental.”