We have summarised three articles to help keep you informed of the latest developments in the industry. This week, our Industry Insights post looks at three important updates from the U.S. Food and Drug Administration (FDA).
The FDA has investigated the risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapy.
At the end of 2023, the FDA noted 22 cases of T-cell cancerfollowing treatment with CAR-T therapy. These reports were received from clinical trials and/or post-marketing adverse event data sources. Fourteen cases have been investigated, with cancers occurring between 1 month and 19 months after the administration of CAR-T cells, with half occurring within the first year. This has led to the FDA pushing for a class-wide boxed warning outlining the risk of T-cell malignancy on all six existing BCMA- and CD19-directed CAR-T drugs.
Johnson & Johnson and Legend Biotech’s Carvykti have added a boxed warning on Carvykti’s label stating that “secondary haematological malignancies, including myelodysplastic syndrome and acute myeloid leukaemia, have occurred following treatment with Carvykti.”
Based on the results of KEYNOTE-A18, the FDA approved pembrolizumab (Keytruda) with chemoradiotherapyon January 12 for people with FIGO 2014 stage III–IVA cervical cancer. This is the first and only anti-PD1 therapy approved in combination with chemoradiotherapy for these patients. It is also the third approved indication for Keytruda in cervical cancer. The two other indications are in combination with chemotherapy for the treatment of persistent, recurrent, or metastatic cervical cancer whose tumours express PD-L1, and as a single agent for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy with tumours that express PD-L1.
The FDA has announced that it considers vaporised hydrogen peroxide to be an established method of sterilisation for medical devices. They hope that this will allow broader adoption of vaporised hydrogen peroxide as a sterilisation method. This is part of an approach to reducing the use of ethylene oxide. Ethylene oxide is currently used to sterilise around half of all medical devices. However, there are concerns about the carcinogenic risk of inhaling ethylene oxide. The Environmental Protection Agency is looking to regulate ethylene oxide, which would tighten emission limits and possibly lead to the closure of sterilisation facilities, resulting in shortages of equipment. The FDA states that vaporised hydrogen peroxide’s “addition as an established sterilization method helps build a more resilient supply chain for sterilized devices that can help prevent medical device shortages.”
