COVID-19 unfortunately is slowing CAR Ts’ progress, starting with delaying the FDA approval process of BMS’ Liso-cel (approval delayed to February 5th 2021), due to a hindered inspection process, while also impacting trial development for new products, and revenue growth for existing ones.
China is fast advancing in the CAR T race with the future launch of Legend biotech’s Ciltacabtagene Autoleucel, in collaboration with Janssen Pharmaceuticals/Johnson & Johnson. China has established itself as a strong driver of innovation in the oncology field, is ripe for strategic collaboration and may witness its first CAR T in market by late 2021; Axicabtagene Ciloleucel (FKC876) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma is the product of Kite Pharma technology transfer to Fosun Pharma. However. the dynamics of China’s commercial/ regulatory policies cannot be ignored, nor its potential move for global biotech leadership.
Commercialization success of CAR Ts remains impacted by its reimbursement, pricing and market access challenges in both the US, EU and elsewhere, where new pricing and payment models are being ‘tested’.
On the horizon, however, is a new frontier of ‘off-the-shelf’ CAR T therapies, now in early-phase clinical testing. They have the potential to solve access hurdles through near immediate treatment delivery and lowered costs to payer systems and patients by bypassing the need to personalize the manufacturing process – and to supersede autologous CAR Ts.