The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in 6 months or less. Bayer secured the privileged position on the strength of data from a midphase trial in patients with non-Hodgkin lymphoma (NHL).
Landing the regulatory status means Bayer will learn whether the FDA shares its enthusiasm for copanlisib within 6 months, rather than the 10 months the agency typically takes to review drugs. The precedent set by other cancer drugs with priority review status suggests the FDA may make a decision about copanlisib in less than 6 months if it is particularly bowled over by the data.
READ FULL STORY HERE- Bayer cancer drug boards path to speedy approval at FDA
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