European Commission Approves Pfizer’s Third-Generation ALK Inhibitor Lorviqua (Lorlatinib) as First-Line Therapy for ALK-Positive Advanced NSCLC, Demonstrating Superior Efficacy Over Xalkori
Feb 12, 2022 03:46
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03:46
Pfizer
Pharmaceutical R&D Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
News on February 11, 2022 /BioValleyBIOON/ --PfizerPfizer recently announced that the European Commission (EC) has approved Lorviqua (lorlatinib, generic name: Lorlatinib, US trade name: Lorbrena):As a monotherapy, it is used for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
In March 2021, lorlatinib (Lorbrena) was approved by the United StatesFDAApproval for expanded indication: For first-line treatment of adult patients with ALK-positive metastatic NSCLC. Results from the Phase 3 CROWN trial show:In the newDiagnosisIn adult patients with ALK-positive NSCLC, compared to Pfizer's first-generation ALK inhibitor Xalkori (crizotinib), Lorviqua as a first-line treatment reduced the risk of disease progression or death by 72%.
In the United States and the European Union, lorlatinib was granted initial approval in November 2018 and March 2019, respectively, for the treatment of patients with ALK-positive metastatic NSCLC, specifically: (1) patients who have progressed on the first-generation ALK inhibitor Xalkori and at least one other ALK inhibitor for metastatic disease; (2) patients treated with the second-generation ALK inhibitor alectinib (brand name: Alecensa,NovartisPharmaceuticals) or certinib (Brand name: Zykadia,Roche Pharmaceuticals) Patients whose disease has progressed after first-line treatment for metastatic disease.
Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC accounts for approximately 80-85% of lung cancer cases. ALK-positiveTumorAccounting for approximately 3-5% of NSCLC cases. Before the advent of targeted therapies and immunotherapies, the 5-year survival rate for patients with advanced NSCLC was only 5%. Xalkori (crizotinib), developed by Pfizer, is the world's first ALK-targeted drug. As a first-generation ALK tyrosine kinase inhibitor (TKI), Xalkori has significantly transformed the clinical treatment landscape for patients with advanced ALK+ NSCLC since its launch in 2011.
Lorbrena is a third-generation ALK inhibitor., specifically developed to suppress the most common driver of resistance to current drugsTumorMutation, and address the issue of brain metastases, the most common site of disease progression in ALK-positive NSCLC. Among patients with ALK-positive lung cancer, up to 40% present with brain metastases at initial diagnosis.
Lorviqua First-Line Treatment Approval Based on Key Phase 3 CROWN Study Data. This was a head-to-head study conducted in 296 patients with previously untreated advanced ALK+ NSCLC, evaluating the efficacy and safety of two ALK-targeted anticancer drugs, lorlatinib and crizotinib, as first-line treatments.
Data shows,Compared with crizotinib, lorlatinib treatment significantly reduced the risk of disease progression or death by 72% (HR=0.28, p＜0.001).。For secondary endpoints, the confirmed objective response rates (ORR) for the lorlatinib treatment group and the crizotinib treatment group were 76% and 58%, respectively. Among patients with measurable brain metastases, treatment with lorlatinib significantly improved intracranial response rates compared to crizotinib (intracranial ORR: 82% vs 23%; complete response rate [CR]: 71% vs 8%), and the proportion of patients with intracranial duration of response (IC-DOR) ≥12 months was significantly higher (79% vs 0%).
BiomarkerDriver mutations have improved the prognosis of ALK-positive NSCLC patients, but innovative therapies are still needed to delay disease progression. The results of the CROWN study indicate,Lorbrena Will Become a First-Line Treatment Option That Changes Clinical Practice for ALK-Positive NSCLCRelevant data have been published in the international medical journal The New England Journal of Medicine (NEJM). For more details, see:First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. (Bioon.com)