An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.
Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that’s a known problem for all drugs in this class.
Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of requiring a transplant. Mirum licensed the drug from Shire in 2018.
Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019 R&D alliance.
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences’ third approved indication for a CAR-T cell therapy.
The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.
The therapeutic vaccine will be based on Gritstone Oncology’s technology and will use antigens from Gilead Sciences. It’s the latest in a string of partnerships Gilead has signed in its search for an HIV cure.
Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.