Immuno-Oncology: Execs Talk About Tumor Response, Biomarkers, Lessons Learned
Leaders from Novartis and other companies developing cellular gene therapies share insights they've gleaned on manufacturing, clinical trials, and value-based pricing.
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ICER's review of available clinical trial data along with associated treatment and hospital costs found that Novartis' Kymriah and Gilead/Kite's Yescarta generally would not break the health care bank.
Risk Evaluation and Mitigation Strategy for Kymriah requires the acute lymphoblastic leukemia treatment be administered by certified centers, while a postmarketing study will assess safety over 15 years. FDA's early approval reflects efforts by the biologics center and new cross-cutting Oncology Center for Excellence to implement a more collaborative review model.
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.