Bayer to pull follicular lymphoma drug Aliqopa from US

09 Nov 2023
firstwordpharma.com
Drug ApprovalAccelerated Approval
Bayer is proposing to voluntarily withdraw the PI3K inhibitor AliqopaPI3K inhibitor Aliqopa (copanlisib) from the US market after the follicular lymphoma treatment failed a post-marketing study, the company confirmed to FirstWord on Thursday.
The drug had been granted an accelerated approval by the FDA in 2017 on the basis of the single-arm CHRONOS-1 trial. As a condition, Bayer was required to demonstrate the drug's clinical benefit in the confirmatory CHRONOS-4 study. However, while detailed results from the trial have not yet been divulged, Bayer says it did not achieve its primary endpoint, so the company is seeking to pull Aliqopa from the US market.
Another setback for the class
The PI3K inhibitor class has seen several market withdrawals, including from the likes of Secura, Gilead Sciences and Incyte, due to a combination of poor tolerability, modest efficacy and growing pressure from competitors such as BTK inhibitorsBTK inhibitors, bispecific antibodies and CAR-T therapies. Last year, an FDA advisory panel voted in favour of having future approvals of PI3K inhibitorsPI3K inhibitors supported by randomised trial data, a stance that was in line with FDA staff scientists (for more, see ViewPoints: FDA and ODAC align on path forward for PI3K inhibitorsPI3K inhibitors).
Meanwhile, Bayer said it intends to "explore what viable access options are available for those patients currently receiving [Aliqopa] with an objective favourable response to the therapy…and for whom there may be no suitable alternative treatments." Bayer added that it does not expect the market withdrawal to have "a relevant financial impact" on the company.
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