Pfizer’s tyrosine kinase inhibitor (TKI) Lorbrena (lorlatinib) has scored a US Food and Drug Administration (FDA) priority review for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC).
The US submission is supported by positive results from Pfizer’s phase III CROWN trial, which hit the primary endpoint of improved progression-free survival (PFS) versus older TKI Xalkori (crizotinib), in people with previously untreated advanced ALK-positive NSCLC.
Lorbrena is being reviewed under the FDA’s real-time oncology review (RTOR) and Project ORBIS pilot programmes, the former of which is intended to create a more efficient review process, with the aim of bringing safe and effective treatments to people as early as possible.
The Project ORBIS pilot programme, which was introduced in 2019, provides a framework for potential concurrent submissions and collaboration reviews with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the United Kingdom.
“The decision by the FDA to evaluate our application for Lorbrena under its innovative review pathways, which aim to speed up availability of potentially life-changing medicines, underscores the significance of the CROWN data and potential impact of Lorbrena as an initial therapy for people with ALK-positive advanced non-small cell lung cancer,” said Chris Boshoff, chief development officer, oncology, Pfizer Global Product Development.
“We look forward to working with the FDA to bring this treatment option to patients as quickly as possible,” he added.
Following the submission and priority review designation, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date for a decision in April 2021.