Today, we have updates from Bristol Myers Squibb, Novartis, Agios Pharmaceuticals, and news about a proposed new framework by the Food and Drug Administration (FDA) for testing CAR-T cell therapy for cancer.
FDA officials are suggesting a stricter approval process for new CAR-T cell therapies. In a recent article, they explained that these therapies should be tested in controlled trials where they must show they can extend survival or delay certain events. These trials should also compare the new treatments with existing standard treatments, including other approved CAR-T therapies, and prove they are better unless there’s a good reason not to. This new process makes it harder for CAR-T therapies to get approved, as they previously only needed to show positive results in single-arm studies.
Bristol Myers Squibb and BioNTech have developed a cancer immunotherapy called pumitamig. A recent study showed that this treatment, when combined with chemotherapy, helped women with an aggressive type of breast cancer. The study found that 61.5% of participants responded to the treatment, and it either shrank tumors or stopped them from growing in 92% of participants. The companies have started a global Phase 3 study and expect results from a different study in China in 2026.
Novartis is investing over $1.7 billion in a London-based startup, Relation Therapeutics, to find new medicines for allergy-related conditions. Relation Therapeutics uses AI-powered technology to discover and develop new drugs. Novartis will use this technology to find and advance new treatments for immune system disorders. Relation Therapeutics has also raised an additional $26 million from investors.
Eli Lilly plans to spend $6 billion to build a new factory in Huntsville, Alabama. This factory will make important ingredients for small molecule and peptide drugs, including a potential obesity pill called orforglipron. The construction will create 3,000 jobs, and the factory will employ 450 people once it’s completed in 2032.
Agios Pharmaceuticals is waiting for the FDA to approve an expanded use for their anemia tablet, mitapivat. The drug is already approved for adults with pyruvate kinase deficiency. Agios is trying to expand its use to other genetic blood disorders that cause anemia. The FDA missed its proposed deadline for a decision, but Agios is working closely with the FDA to finalize the details. Analysts believe an approval is likely soon.