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Pfizer's Third-Generation ALK Inhibitor Lorviqua Recommended for First-Line Treatment of ALK-Positive Advanced NSCLC in EU

Dec 26, 2021 01:45 CST Updated 01:45
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Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


December 25, 2021 /BioValleyBIOON/ --Pfizer(Pfizer) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending approval.Lorviqua (lorlatinib, trade name in the U.S.: Lorbrena): First-line treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)The CHMP's opinion will be submitted to the European Commission (EC) for review, which typically makes a final decision within two months.

In March this year, lorlatinib (Lorbrena) was approved by the United States.FDAApproval 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 reduced the risk of disease progression or death by 72%.

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), introduced 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 of 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. In patients with ALK-positive lung cancer, up to 40% present with brain metastases at initial diagnosis.

Pfizer Global Product DevelopmentTumorChief Development Officer Chris Boshoff, M.D., stated: "In the past few decades, we have come to understand that ALK-positive advanced non-small cell lung cancer is a complex disease, affecting nearly 40% of...DiagnosisPatients with brain metastases are particularly challenging. The positive opinion from the CHMP reinforces Lorviqua as an effective first-line treatment option for ALK-positive advanced non-small cell lung cancer patients in Europe.

United StatesFDAThe expanded indication approval and the EU CHMP positive opinion are both based on data from the pivotal Phase 3 CROWN study. This is 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).In addition, in patients with measurable brain metastases,Compared with crizotinib, lorlatinib treatment significantly improved intracranial response rate (objective response rate [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. Results from the CROWN study suggest that Lorbrena has the potential to become a first-line treatment option that could transform clinical practice for ALK-positive NSCLC. Relevant 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)