Bayer announced the voluntary withdrawal of its new drug application for copanlisib in combination with standard chemoimmunotherapy regimens as treatment for relapsed follicular lymphoma (FL) in adult patients who have received at least two prior systemic therapies.
In 2017, copanlisib was granted U.S. Food and Drug Administration (FDA) accelerated approval based on the results of an open-label, single-arm, phase II study, dubbed CHRONOS-1. However, the phase III trial the FDA looked to for clinical benefit confirmation, CHRONOS-4, did not meet its primary endpoint.
CHRONOS-4 evaluated the addition of copanlisib to standard treatment regimens. The primary endpoint was progression-free survival benefit in comparison to standard treatment alone.
Currently, copanlisib is approved in the U.S., China, and Taiwan as a monotherapy for the treatment of relapsed FL in adults who have received at least two prior systemic therapies.
“Bayer is exploring access options for patients currently receiving [copanlisib] who have experienced a favorable response to treatment, whose treating physician supports continuing treatment with [copanlisib], and for whom there may be no suitable alternative treatments available,” the company said in a press release.
Source: Bayer, November 13, 2023.
