Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Can Spectrum shave 2m off brigatinib's approval timeline? I believe the answer could be yes.

Regarding brigatinib, the agency stated in Ariad correspondence

FDA Response: The proposal that safety and efficacy data from ALTA in the original NDA in which all patients have completed a minimum of 16 weeks follow up is acceptable.

And looking at the brigatinib protocol

Confirmed Objective Response Rate (ORR) as Assessed by Investigator [ Time Frame: Screening, at 8-week intervals thereafter (on Day 1 of every odd-numbered cycle) through 15 cycles and every 3 cycles thereafter until disease progression or up to data cut-off date: 29 Feb 2016 (approximately up to 20 months) ]

So for their trial, you'd take a scan at 2m and then at 4 months (note - the same as the MDA pozi trial) to get confirmed ORR. For Spectrum's pozi trial, you get a scan at month 1 then another at month 2 for potential confirmation. So this could shave 2 months off of the brigatinib timeline.