GSK expedites Blenrep timelines as it eyes second chance in multiple myeloma

GSK wants to present Blenrep to regulatory bodies sooner.

The UK pharma will submit Blenrep in second-line multiple myeloma to US, European and Japanese authorities in the second half of 2024, which is earlier than the original 2025 guidance, according to its first-quarter earnings report. The filings will be based on positive outcomes from the Phase 3 DREAMM-7 and DREAMM-8 studies reported earlier this year.

Emma Walmsley

“We’re encouraged by the data from DREAMM-7, which showed a tripling of progression-free survival,” CEO Emma Walmsley said on an investor call Wednesday. Nonetheless, “we’ve obviously got a journey to go on with the regulators,” she said, adding that more detail on a path forward will be provided once DREAMM-8 data are presented at this year’s ASCO meeting.

Blenrep won FDA accelerated Click here to view original post

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