FDA Expands use of Zykadia® in First-Line ALK-Positive Non-Small Cell Lung Cancer

The US Food and Drug Administration (FDA) approved the expanded use of Zykadia® (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose cancers are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test.

About Zykadia

Zykadia is an oral, selective inhibitor of ALK, a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers including NSCLC. Zykadia is currently approved in over 69 countries worldwide. Approximately 3-7% of all patients with NSCLC have an ALK gene rearrangement.2

The approval of Zykadia is based on results from the ASCEND-4 clinical trial. The study demonstrated that patients treated with first-line Zykadia had an average progression-free survival (PFS) of 16.6 months compared to 8.1 months  for patients treated with standard first-line pemetrexed-platinum chemotherapy and pemetrexed maintenance.1,3

Overall intracranial response rate in patients with measurable brain metastases was 57% for patients treated with Zykadia, versus 22% for patients treated with chemotherapy.

About ASCEND-4

ASCEND-4 is a comparative global clinical trial to Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK-positive advanced NSCLC who received no prior therapy for their advanced disease. Patients received Zykadia orally or standard pemetrexed-based platinum doublet chemotherapy followed by pemetrexed maintenance and were directly compared.

Of 376 patients, 189 (59 with brain metastases) were treated with Zykadia and 187 (62 with brain metastases) with chemotherapy.  Patients treated with first-line Zykadia had a median time to cancer progression of 16.6 months, compared to 8.1 months for patients treated with standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.  Patients without brain metastases receiving Zykadia experienced an average time to cancer progression of 26.3 months compared with 8.3 months among patients treated with chemotherapy. 

References

  1. Zykadia® (ceritinib) Full Prescribing Information.
  2. Lovly, C., L. Horn, W. Pao. 2016. Molecular Profiling of Lung Cancer. My Cancer Genome. https://www.mycancergenome.org/content/disease/lung-cancer/. (Updated March 28). Accessed March 22, 2017.
  3. Soria JC, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): A randomized, open-label Phase 3 study. The Lancet. 2017; 389(10072):917-929.

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