February 11, 2021
Bristol Myers-Squibb (BMS) has set a 24-day production target for Breyanzi and set up a digital platform to let physicians and patients track manufacture of the lymphoma cell therapy in real-time.
The US Food and Drug Administration (FDA) cleared Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma this month.
A BMS spokeswoman told us “BMS plans to manufacture Breyanzi for each individual patient at its state-of-the-art cellular immunotherapy manufacturing facilities, initially in Bothell, Washington and then also expanding to later manufacture it in Summit, New Jersey to support clinical and commercial capacity and accommodate patient geographic spread.”
Image: iStock/Iana Miroshnichenko
BMS added the Bothell facility when it acquired Celgene, the parent company of Breyanzi’s original developer Juno Therapeutics – for $79 billion in early 2019.
The site was hit with a FDA Form 483 in October. BMS confirmed the inspection had taken place a month later during its Q3 earnings call a month later but did not mention the 483.
When ask if the Bothell facility has now passed an FDA inspection, the spokeswoman told us “The site was inspected in November.”
Breyanzi was originally filed for review in December 2019 with the FDA setting a PDUFA date of August 17, 2020.
However, in June BMS said the decision had been delayed to give the agency more time to review additional data it had request.
In November the firm announced an additional delay. It said the COVID-19 pandemic had prevented FDA reviewers inspecting the Lonza facility in Houston, Texas where the viral vector for Breyanzi is made.
BMS’ plan is to produce each patient batch of Breyanzi less than a month – specifically 24 days – after cells are harvested.
The firm said it plans to support “the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information. ”
Using the platform patients will be able to track production and receive support. BMS also said it will provide patients with wearable technology to “help them track their temperature in real time.”
Looking ahead, BMS is also investing in next-generation technologies to improve the manufacturing process and reduce cost across the company’s global facilities by making it faster, simpler and more precise.
The spokeswoman said, the firm is “investing in, evaluating and developing new manufacturing platforms to advance scientific innovation in cellular therapies,” adding “We are also continuing to explore expanding our manufacturing footprint globally.”
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