A total of 15 antibody therapeutics were granted a first approval in the US during 2014-2015. Approximately half (53%) of these products were approved as treatments for cancers, including non-small cell lung cancer (necitumumab, nivolumab), melanoma (nivolumab, pembrolizumab), gastric cancer (ramucirumab), multiple myeloma (daratumumab, elotuzumab), acute lymphoblastic leukemia (blinatumomab) and neuroblastoma (dinutuximab). To aid development planning, we determined the mean and median elapsed time from entry into clinical study to first US approval for 7 of these 8 products. Dinutuximab was excluded because a substantial amount of the development was done by government or non-profit organizations. The mean (median) development time for the 7 products was 8.6 (8.9) years. The product with the shortest development time (4.6 years) was pembrolizumab (Keytruda®), which was the first approved antibody that targets the immune checkpoint PD-1. Pembrolizumab had FDA’s breakthrough therapy designation and orphan product designation, and its marketing application received a priority review and accelerated approval. The accelerated approval program allows FDA to approve a drug that treats a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients, but confirmatory clinical trials must be conducted after approval.
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An international non-profit supporting antibody-related research and development.
