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April 28, 2021

LoA Update: Pfizer’s binimetinib takes a 17-point hit to FDA approval prospects in AML due to Phase II termination

The likelihood of approval (LoA) for Pfizer’s binimetinib in acute myeloid leukaemia (AML) plummeted 17 points on 21 April, according to GlobalData’s LoA data.

By Sean Rai-Roche

The likelihood of approval (LoA) for Pfizer’s binimetinib in acute myeloid leukaemia (AML) plummeted 17 points on 21 April, according to GlobalData’s LoA data. The fall was triggered after the Phase II trial changed its status to terminated, on 20 April.

Previously, binimetinib had an LoA of 28% but this has now dropped to 11% following GlobalData’s LoA analysis, which uses a combination of machine learning and its proprietary algorithm, recalculated the score. According to results published in December 2020, binimetinib had minimal response for MAP-ERK kinase (MEK) inhibition in AML, along with a tolerable safety profile. The study, sponsored by M.D. Anderson Cancer Centre, has changed its status to terminated because of slow accrual, according to ClinicalTrials.gov.

Pfizer acquired Array in July 2019, with the expansion of binimetinib as a rationale for the acquisition, analyst reports at the time showed. On 30 March 2020, this news service reported that binimetinib, which is also being investigated within a triplet in Phase II ANCHOR trial in colorectal cancer (CRC), is unlikely to progress to a later Phase III because it is not increasing efficacy over the doublet and brings an additional side- effect burden.

Sean Rai-Roche is a Healthcare Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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