Nivolumab Intravenous Infusion Approved for First-Line Treatment of Metastatic or Recurrent Non-Squamous NSCLC in Taiwan
The Taiwan Food and Drug Administration (TFDA) has approved Opdivo® (nivolumab) intravenous infusion in combination with bevacizumab and chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC with no EGFR mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
This approval is based on results of the phase III ONO-4538-52/TASUKI-52 study, which demonstrated a statistically significant improvement in the primary endpoint of progression-free survival in patients treated with nivolumab versus placebo in combination with bevacizumab and chemotherapy.
MHRA Approves Atezolizumab to Treat NSCLC in England
The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom has approved the use of atezolizumab to treat NSCLC. It is the first immunotherapy approved for patients with early-stage NSCLC whose tumors express the PD-L1 mutation and who have undergone surgery and chemotherapy. England is only the second country in Europe to make this cutting-edge treatment available.
Clinical trials have shown atezolizumab (Tecentriq) can significantly reduce the risk of cancer recurrence or death by 34% in patients with early-stage NSCLC, following surgery and chemotherapy. More than 850 patients in England are expected to be eligible for the drug in the first year, rising to more than 1,000 in the third year.
EC Approves Lorlatinib as a First-Line Treatment for ALK-Positive Advanced Lung Cancer
The European Commission (EC) has granted marketing authorization for Lorviqua® (lorlatinib, available in the United States under the brand name Lorbrena®) as monotherapy for the treatment of adult patients with treatment-naïve ALK-positive advanced NSCLC.
The approval for the first-line use of lorlatinib was based on the results of the pivotal phase III CROWN trial, in which lorlatinib reduced the risk of disease progression or death by 72% compared to crizotinib. The CROWN trial is a randomized, open-label, parallel 2-arm trial in which 296 patients with previously untreated advanced ALK-positive NSCLC were randomized 1:1 to receive lorlatinib monotherapy or crizotinib monotherapy.