Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Still reel­ing from Ze­ju­la set­back, Glax­o­SmithK­line gets a breather with ex­pand­ed PD-1 ap­proval

A lit­tle less than four months ago, Glax­o­SmithK­line shep­herd­ed the sev­enth PD-1 across the fin­ish line in Jem­per­li, win­ning ac­cel­er­at­ed ap­proval for a spe­cif­ic sub­set of pa­tients with en­dome­tri­al can­cer.

On Tues­day, the FDA hand­ed GSK a much broad­er la­bel.

Jem­per­li’s ac­cel­er­at­ed OK was ex­pand­ed to all adult pa­tients with mis­match re­pair-de­fi­cient (dMMR) re­cur­rent or ad­vanced sol­id tu­mors who have pro­gressed or stag­nat­ed on ear­li­er ther­a­py. Pre­vi­ous­ly, the drug was on­ly able to be pre­scribed for en­dome­tri­al can­cer pa­tients with dMMR — i.e en­dome­tri­al tu­mors that con­tains ab­nor­mal­i­ties that af­fect the prop­er re­pair of DNA in­side the cell.

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