Cancer Immunotherapies Have FDA, Industry Looking For New Endpoints
Modifying existing tumor response criteria or developing novel intermediate endpoints could address shortfalls in immuno-oncology efficacy assessments with traditional endpoints such as overall response rate and progression-free survival.
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Unprecedented wave of cancer immunotherapies is in some ways a mirror image of AIDS crisis as FDA explores new tools to accelerate drug development, including modeling techniques and statistical approaches to efficacy. It's an effort to encourage a regulatory revolution in response to a massive number of products in development as opposed to the AIDS-era effort to get products studied.
Long-term or open-ended treatment with PD-1/PD-L1 inhibitors is a burden for patients and the healthcare system and does not fit the biological paradigm of cancer immunotherapies, experts say; however, challenges to studying shorter durations include fears of undertreatment and patient objections to stopping a therapy that appears to be working.