Will the FDA grant Accelerated Approval to the first personalized mRNA cancer vaccine by the end of 2028?

mRNA's Pivot to Personalized Cancer

RNA-based cancer vaccines have demonstrated impressive results, with key melanoma treatments reducing cancer recurrence by 44% when combined with immunotherapy (simulated late 2025 context). With over 60 candidates in clinical development, and first commercial approvals anticipated by 2029, the pace is extremely fast. The high 'Yes' vote is based on the expectation that at least one candidate (likely for melanoma or an aggressive, hard-to-treat cancer like pancreatic cancer) will show sufficiently promising Phase II data to qualify for the FDA’s Accelerated Approval pathway, thus beating the standard 2029 projection and reaching patients by the end of 2028.