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 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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As the weather heats up in the western hemisphere, the temperatures are not the only thing increasing…
In Pharmaland, the oncology space traditionally sees either interesting new data published or a spate of post American Society of Clinical Oncology (ASCO) filings. The summer doldrums often give way to a faster pace in the fall.
One thing we have been following over the last two years is the T790M race to market in EGFR mutant lung cancer. Clovis Oncology announced last week that they have begun their rolling NDA submission for rociletinib (CO–1686), but what about their keen rival, AstraZeneca with AZD9291?
The company presented new data for AZD9291 jn the EGFR mutant lung cancer upfront setting, but no formal announcement was made about the regulatory status.
There are some potentially interesting new developments to report here, though.
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