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    1. About ALK+ NSCLC Infographic

    2. An Interactive Guide to ALK+ NSCLC

    3. About Zykadia and ALK+ NSCLC Fact Sheet

    4. History and Development of Zykadia

  • Jun 02, 2014 10:00 PM WES

    Novartis study shows Zykadia™ shrank tumors in the majority of patients with ALK+ NSCLC, regardless of prior ALK treatment

    • Ceritinib achieved overall response rate of 58.5%, with a median progression-free survival of 8.2 months1

    • Similar findings were observed in patients who started the study with brain metastases, addressing one of the biggest challenges in treating ALK+ NSCLC1

    • Zykadia is the only FDA-approved therapy for patients with ALK+ metastatic NSCLC who have progressed on or are intolerant to crizotinib2
     
    Basel, June 2, 2014 Novartis today announced data showing Zykadia (ceritinib, previously known as LDK378) shrank tumors in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC), including those who had received previous treatment with an ALK inhibitor as well as patients receiving one for the first time. Results were also observed in patients with ALK+ NSCLC who entered the study with brain metastases1.
     
    The study is being presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
     
    “Ceritinib demonstrated a high level of activity in patients with ALK+ NSCLC regardless of whether or not they were previously treated with an ALK inhibitor,” said lead investigator Dong-Wan Kim, MD, PhD, Seoul National University Hospital. “Another noteworthy finding in this study population is that ceritinib exhibited activity among patients whose cancer had metastasized to the brain, which is currently one of the biggest challenges in treating ALK+ NSCLC.”
     
    Among a combined population of 246 NSCLC patients, ceritinib achieved an overall response rate (ORR) of 58.5% and a median progression-free survival (PFS) of 8.2 months. Of these, 124 patients entered the trial with brain metastases and achieved an ORR of 54.0% and a median PFS of 6.9 months. The most common adverse events, occurring in more than half of patients, were diarrhea, nausea, vomiting, abdominal pain and fatigue
    1.
     
    Approximately 2-7% of patients with NSCLC harbor the ALK gene rearrangement, which causes cancer growth
    3. These patients are candidates for treatment with a targeted ALK inhibitor. Patients with ALK+ NSCLC are often younger than the average NSCLC patient, and in many cases have never smoked4.
     
    “We are encouraged that ceritinib has demonstrated consistent activity as we analyze data from additional patients with longer follow-up, further supporting the potential of ceritinib to make a difference in the lives of patients with ALK+ NSCLC,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.
     “The recent FDA approval of Zykadia brought an important new treatment option to patients in the US and we are pleased to be working with regulatory authorities around the world to bring ceritinib to additional patients.”
     
    The study presented at ASCO served as the basis for the US Food and Drug Administration (FDA) approval of Zykadia in April 2014, which followed the FDA’s Breakthrough Therapy designation, and occurred less than three and a half years after the first patient entered a clinical trial. Additional ongoing regulatory reviews are currently underway in the European Union, Argentina and Switzerland.

  • Full Press Release

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.


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