Lorviqua (lorlatinib) Yevropa Ittifoqida tasdiqlanishi arafasida: samaradorlik Xalkoriga qaraganda ancha yaxshi!

Pfizer bugun Yevropa Dorilar Agentligining (EMA) Inson Foydalanish uchun Dori vositalari Qo'mitasi (CHMP) Lorviqua ni tasdiqlashni tavsiya qilgan ijobiy sharh xulosasini chiqarganini e'lon qildi.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.

Joriy yilning mart oyidalorlatinib 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 uchinchi avlod ALK inhibitori bo'lib, hozirgi dori vositalariga qarshilik ko'rsatadigan eng keng tarqalgan o'simta mutatsiyalarini inhibe qilish va ALK-musbat NSCLCda kasallikning eng ko'p tarqaladigan joyida miya metastazlarini bartaraf etish uchun maxsus ishlab chiqilgan. ALK{2}}musbat o'pka saratoni bilan og'rigan bemorlarning 40 foizida dastlabki tashxisda miya metastazlari paydo bo'ladi.

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, lorlatinibvaKrizotinib, ALK va NSCLC bilan ilgari davolanmagan 296 ta bemorlarda birinchi{0}}davolash bosqichi sifatida.

Ma'lumotlar shuni ko'rsatdiki, lorlatinib bilan davolash krizotinib bilan solishtirganda kasallikning rivojlanishi yoki o'lim xavfini sezilarli darajada 72 foizga kamaytiradi (HR =0.28, p.<0.001). in="" addition,="" in="" patients="" with="" measurable="" brain="" metastases,="">lorlatinibdavolash krizotinib bilan solishtirganda intrakranial javob darajasini sezilarli darajada yaxshilagan (ob'ektiv javob darajasi ORR: 82 foizga nisbatan 23 foiz; to'liq javob darajasi CR: 71 foizga qarshi 8 foiz) va javobning intrakranial davomiyligi (IC{{4}) bo'lgan bemorlarning nisbati }DOR) 12 oydan katta yoki unga teng bo'lgan vaqt sezilarli darajada yuqori (79 foizga nisbatan 0 foiz).

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.