J&J preps to enter cell therapy space as CAR-T approval decision approaches

J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product.

J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China .

Nearly four years on, and the firm is now preparing for a potential commercial launch, with the imminent US Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) target action date set for November 29.

“This is going to be our first entry into cell therapy, and so the total team from R&D to supply chain to commercial has been really, really invested in this asset over the past couple of years preparing to launch,” an executive from the firm said during its third quarter financial call this week.

“I think the results that you’ve all seen, and they’re really deep and durable responses that have been proven through our clinical programs really highlight that this is going to be a really meaningful and transformational asset for patients.”

Being studied in a clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment, Cilta-cel received Breakthrough Therapy Designation granted in the US in December 2019.

The proposed product is an autologous cell therapy, made from patient’s own T cells that have been genetically engineered and administered as a single dose infusion. If approved, it will become the fifth CAR-T cell therapy in the US, making J&J the fourth firm to achieve success in the field. The approved therapies are Novartis’ Kymriah (tisagenlecleucel), Gilead/Kite’s Yescarta (axicabtagene ciloleucel) – both approved in 2017 – and Bristol Myers Squibb’s Abecma (ide-cel) and Breyanzi (lisocabtagene maraleucel), both of which were approved this year.

“As we have been planning the launch, we’re really taking a thoughtful approach to scaling our global manufacturing, making sure that we’re learning from those who come before us, and that we’re really going to plan to deliver an optimal patient experience and patient treatment or provider treatment center experience as well as we scale up,” the company representative told investors.

“The team has been working very heavily on this and we’re gearing up for what we believe will be a very successful launch for patients hopefully later this year. I also want to call out the very strong partnership that we have with Legend Biotech, where we’ve been attached at the hip throughout and we’re so excited to be working in partnership with them to be bringing that to market. I’m looking forward to a good launch later this year.”

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