The ranks of B7-H3-targeting antibody-drug conjugates under development in China have seen their first dropout, although elsewhere there are two FGFR2b-directed ADCs with first-in-class potential on the horizon. Meanwhile, there have been other discontinuations of KRAS G12C inhibitors and anti-BCMA CAR-T cell therapies in the country, while new players have surfaced in the areas of mRNA cancer vaccines and amyloid-beta-targeting antibodies for Alzheimer’s disease.

The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

Bristol Myers Squibb’s head of major markets, Monica Shaw, wants to improve access to lifesaving therapies. Payers and politicians must be persuaded to loosen their purse strings – and open their minds.

The Sweden-headquartered biotech has emphasized the promising survival data in a head and neck cancer study of setanaxib rather than the NOX inhibitor’s inability to shrink tumors.