Bayer cancer drug boards path to speedy approval at FDA

Bayer sign
FDA has awarded priority review status to Bayer's PI3K inhibitor copanlisib in follicular lymphoma.

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.

Bayer is building its pitch to the FDA on an open-label, single-arm phase 2 trial of copanlisib in 142 patients, 141 of whom had relapsed or refractory indolent NHL. The German conglomerate shared a look at data from the trial at the American Association for Cancer Research meeting last month.


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That data drop linked the PI3K inhibitor to an objective response rate (ORR) of 59.2%, a performance that was strong enough for the study to meet its primary endpoint. The complete response rate came in at 12%. And the median duration of response clocked in at 98 weeks.

Bayer reported comparable figures among the 104 patients in the trial with follicular lymphoma, a type of NHL and the indication in which the FDA has awarded copanlisib the VIP treatment. Copanlisib achieved ORR and complete response rates of 58.7% and 14.4%, respectively, among this subset of participants, although the median duration of response fell short of that achieved by the broader population at 52 weeks.

The progress of copanlisib has prompted analysts at Bryan Garnier to reevaluate their assessment of the drug’s potential, Reuters reports. Bryan Garnier currently forecasts peak sales of $666 million but plans to dial this up. Bayer’s own forecasts have peak sales coming in somewhere above $555 million.

By rolling out the red carpet, the FDA has brought forward the date on which Bayer can potentially begin racking up its first sales. The priority review status covers the third-line use of copanlisib. Bayer is also trialing copanlisib in combination with rituximab as a second-line treatment for indolent NHL.

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