The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of 28 December 2024. Credit: grandbrothers via Shutterstock.

Florida-based biotech Xcovery has received an acceptance of its new drug application (NDA) from the US Food and Drug Administration (FDA) for Bemena (ensartinib) to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).  

The regulatory agency will provide a decision on the approval of the treatment by 28 December 2024 under the Prescription Drug User Fee Act. 

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Jointly developed by Xcovery and Betta Pharmaceuticals, Bemena is an ALK inhibitor, which targets the activity of the ALK protein that is commonly overactive in certain cancer cells. Bemena gained approval in China for the treatment of ALK-positive NSCLC in 2020. 

The application is based on data from the Phase III eXalt3 study (NCT02767804), originally published in JAMA Oncology in September 2021. The 290-patient study met its primary endpoint, demonstrating a median progression-free survival of 25.8 months with Bemena, compared to 12.7 months with Pfizer’s cancer drug Xalkori (crizotinib). Patients with baseline brain metastases experienced an intracranial response rate of 64% with Bemena, compared to 21% with Xalkori. The drug also had a favourable safety profile. 

While the NDA is based on a trial that evaluated the drug for patients who had not received any prior ALK inhibitors, it is currently being investigated in several Phase II and III trials in other settings. The Phase II paediatric MATCH trial (NCT03213652) is investigating Bemena in patients with relapsed or refractory advanced solid tumours, non-Hodgkin lymphoma or histiocytic disorders with ALK or ROS1 genomic alterations.

In December 2022, Xcovery began re-recruiting patients into the trial, after it was previously suspended due to drug supply issues, as per ClinicalTrials.gov. The trial is estimated to conclude at the end of this year.  

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In addition to Xalkori, another major competitor for Bemena in the space is Pfizer’s ALK inhibitor Lorbrena (lorlatinib), which was first approved for NSCLC in March 2021. The drug generated $539m last year, as per Pfizer’s annual report. GlobalData expects the drug to continue its upward sales trajectory and pull in $884m in global sales in 2029.  

GlobalData is the parent company of Pharmaceutical Technology. 

In the announcement accompanying the NDA, Xcovery’s chief medical officer Giovanni Selvaggi said: “The FDA’s acceptance of this NDA represents a key milestone for Xcovery in its mission to bring ensartinib as a novel and distinct first-line therapeutic option to ALK-positive NSCLC patients.”