Lorviqua (lorlatinib) er um það bil að verða samþykkt í ESB: virknin er verulega betri en Xalkori!

Pfizer tilkynnti í dag að nefnd um lyf fyrir menn (CHMP) Lyfjastofnunar Evrópu (EMA) hafi gefið út jákvætt endurskoðunarálit þar sem mælt er með samþykki Lorviqua (lorlatinib): first-line treatment of anaplastic lymphoma kinase (ALK)-positive advanced non- Adult patients with small cell lung cancer (NSCLC). The CHMP's opinion will be submitted to the European Commission (EC) for review, which usually makes a final review decision within 2 months.

Í mars á þessu ári,lorlatinib was approved by the U.S. FDA to expand the indication: for the first-line treatment of adult patients with ALK-positive metastatic NSCLC. Results from the Phase 3 CROWN trial showed that Lorviqua reduced the risk of disease progression or death by 72 percent compared with Pfizer's first-generation ALK inhibitor Xalkori (crizotinib) in adults with newly diagnosed ALK-positive NSCLC.

Lung cancer is the number one cause of cancer-related death worldwide. NSCLC accounts for approximately 80-85 percent of lung cancers. ALK-positive tumors account for approximately 3-5 percent of NSCLC cases. Prior to targeted therapy and immunotherapy, the 5-year survival rate for patients with advanced NSCLC was only 5 percent . Xalkori (crizotinib) is the world's first ALK targeted drug launched by Pfizer. Xalkori is a first-generation ALK tyrosine kinase inhibitor (TKI). Since its launch in 2011, it has greatly changed the prognosis of patients with advanced ALK plus NSCLC. Clinical treatment.

Lorbrena er þriðju-kynslóð ALK hemlar sem er sérstaklega þróaður til að hamla algengustu æxlisstökkbreytingum sem knýja fram ónæmi gegn núverandi lyfjum og til að takast á við meinvörp í heila á algengasta stað sjúkdómsframvindu í ALK-jákvæðum NSCLC. Meðal sjúklinga með ALK-jákvætt lungnakrabbamein fá allt að 40 prósent meinvörp í heila við fyrstu greiningu.

The US FDA's expanded indication approval and the EU CHMP's recommendation for approval are based on data from the pivotal Phase 3 CROWN study. This is a head-to-head study evaluating the efficacy and safety of two ALK-targeted anticancer drugs, lorlatinibogcrizotinib, sem fyrsta-línumeðferð hjá 296 áður ómeðhöndluðum sjúklingum með langt genginn ALK og NSCLC.

Gögnin sýndu að meðferð með lorlatinibi dró verulega úr hættu á framgangi sjúkdóms eða dauða um 72 prósent samanborið við crizotinib (HR=0.28, p.<0.001). in="" addition,="" in="" patients="" with="" measurable="" brain="" metastases,="">lorlatinibmeðferð bætti verulega svörunartíðni innan höfuðkúpu samanborið við crizotinibi (hlutlæg svörunarhlutfall ORR: 82 prósent á móti 23 prósent; heildarsvörunarhlutfall CR: 71 prósent á móti 8 prósent), og hlutfall sjúklinga með svörun innan höfuðkúpu (IC{{4} }DOR) Stærra en eða jafnt og 12 mánuðir var marktækt hærra (79 prósent á móti 0 prósent).

Biomarker-driven drugs have improved outcomes for patients with ALK-positive NSCLC, but innovative therapies are still needed to slow disease progression. The CROWN study results demonstrate that Lorbrena has the potential to be a first-line treatment option that transforms clinical practice in ALK-positive NSCLC. Relevant data have been published in the international medical journal "New England Journal of Medicine" (NEJM). See: First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer.