AstraZeneca’s AZD9291 osimertinib is approved as Tagrisso
It’s Friday 13th, a day often feared by the superstitious, but for AstraZeneca it certainly portended good news with the FDA approval of AZD9291 or osimertinib (now Tagrisso) in EGFR T790M mutation-positive lung cancer – three months ahead of the PDUFA date. Jonathan Rockoff, a reporter at the WSJ, was the first to announce it in my Twitter stream:
Tagrisso, new lung cancer drug from $AZN, is approved by @US_FDA, w/ companion diagnostic from $ROG.VX to identify EGFR resistance mutation
— Jonathan Rockoff (@jonathanrockoff) November 13, 2015
Tagrisso 80 mg. Picture credit: AstraZeneca
The FDA announcement for Tagrisso (generic name is osimertinib) can also be found here and the actual label here.
Note that it is now available under accelerated approval, based on tumor response rate and duration of response. This means that phase III confirmatory trials, including survival data will be needed for full approval.
As part of our ongoing series on the T790M niche, this is also a timely opportunity to catch up with the latest data that was presented earlier this month at the AACR-NCI-EORTC Cancer Therapeutics and Molecular Targets meeting in Boston.
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