Rinki Kapoor, Tahel Noy, and Naval Shanware for BioProcess Online
In 2017, the U.S. FDA approved two groundbreaking chimeric antigen receptor (CAR) T-cell therapies — Kymriah and Yescarta — to treat acute lymphoblastic leukemia and diffuse large B-cell lymphoma, respectively. These novel therapies utilize a patient’s own immune cells to attack and kill the cancer, and they have shown promise in treating and, in a few cases, “curing” otherwise incurable hematological malignancies.
Despite the breakthrough nature of the clinical data, these first-wave CAR-T 1.0 therapies are struggling to find commercial success, due to factors including:
Despite these commercial challenges, the clinical promise has helped trigger substantial follow-on research to harness CAR-T to treat other cancers, including multiple myeloma and solid tumors. In keeping with the tremendous excitement for these therapies, investment in a second wave of CAR-T drugs is strong, with more than 270 trials underway and exponential market growth estimated at nearly 50% between 2019 and 2028.
As this second wave of CAR-T therapies begins coming to market in the next five years, their manufacturers will need to anticipate and prepare to address many of the same commercial challenges as their predecessors, as well as several additional ones, including:
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