GSK's Blood Cancer Drug Review Extended As FDA Seeks More Data

The US Food and Drug Administration (FDA) on Wednesday extended the review period for the Biologics License Application (BLA) for GSK plc’s (NYSE:GSK) Blenrep combinations for relapsed or refractory multiple myeloma patients who have received at least one prior line of therapy.

GSK is consolidating in the middle of its 52-week range. See the chart here.

The new Prescription Drug User Fee Act (PDUFA) action date is Oct. 23, which allows the FDA to review additional information provided in support of the application.

The BLA is supported by efficacy results shown by Blenrep combinations in the pivotal DREAMM-7 and DREAMM-8 phase 3 trials in relapsed or refractory multiple myeloma.

Also Read: UK Becomes First ...