Avid Bioservices Inc (CDMO)

[dia76ca]

Sometimes the FDA offers a surprise. This is the sort of thing that makes you glad that PPHM has Dr.Garnick on our team.

AstraZeneca just got an early approval (PhII) based on PFS:


Quote:
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The FDA's approval is based on Phase II data in which the drug charted a 34% objective response rate for an average of 7.9 months. Treatment with olaparib also led to progression-free survival (PFS) of 11.2 months versus 4.3 months on placebo.

Those same results weren't enough to convince a panel of FDA advisers over the summer. In June, the agency's cancer drug committee picked apart olaparib's potential, taking issue with its failure to significantly improve overall survival, pointing to a few alarming adverse events and expressing doubts in the reliability of its PFS data. The group voted 11-2 against recommending an early approval for the drug, asking the agency to wait out AstraZeneca's ongoing Phase III study on olaparib before green-lighting it.

But AstraZeneca came back with additional information supporting the drug's use in thrice-failed patients who carry BRCA mutations, the FDA said, which was apparently enough to sway the agency's oncology division, affirming cancer chief Richard Pazdur's penchant for hurrying along new treatments that could change the standard of care.
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LINK:http://www.fiercebiotech.com/story/astrazeneca-grabs-surprise-early-approval-its-2b-cancer-contender/2014-12-19?utm_medium=nl&utm_source=internal