Novartis lung cancer drug Zykadia® recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib

• If approved, Zykadia (ceritinib) would be the first treatment option for patients in Europe with ALK+ NSCLC previously treated with crizotinib
  
• ALK+ NSCLC is driven by a rearrangement of the ALK gene, which is responsible for cancer cell growth in 2-7% of patients with NSCLC¹
  
• Positive CHMP opinion represents a critical milestone for Zykadia; now approved in several countries worldwide, with additional regulatory filings underway

Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for Zykadia^® (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib². If approved in the European Union (EU), Zykadia will be the first treatment option to address an unmet medical need for patients with ALK+ NSCLC previously treated with crizotinib.

“Patients with advanced ALK+ NSCLC have few options when their cancer does not respond to currently approved therapy,” said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. “As a leader in the development of precision oncology medicines, Novartis is committed to developing and bringing to market new treatments for patients with ALK+ NSCLC. This positive CHMP opinion for Zykadia brings us one step closer to providing the lung cancer community with new hope in the fight against this terrible disease.”

Each year, there are 1.6 million people diagnosed with lung cancer, the leading cause of cancer death worldwide³. The most common type of lung cancer is NSCLC, accounting for 85-90% of all cases⁴. Of those, 2-7% are driven by a rearrangement of the ALK gene, which increases the growth of cancer cells and can be identified by a molecular test of the cancer tumor¹. Despite significant treatment advances for patients with ALK+ NSCLC, disease progression is often inevitable and more treatment options are needed⁵.

In the EU, the European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months of the CHMP recommendation. The decision will be applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein. Zykadia is currently approved in the United States, Mexico, Chile, South Korea, Guatemala and Ecuador. Additional regulatory reviews are underway in North America, South America, Central America and Asia.

The CHMP recommendation for Zykadia was based on results from two global, multicenter, open-label, single-arm studies (Study A and Study B). Comparative efficacy data from randomized clinical studies are not yet available. The primary efficacy endpoint for these studies was overall response rate (ORR), including complete response and partial response, for patients who were treated with a 750 mg dose of Zykadia, confirmed by repeat assessments performed not less than four weeks after the criteria for response was first met. Additional evaluations included duration of response (DOR) and progression-free survival (PFS) by investigator and blinded independent review committee (BIRC) assessment, and overall survival (OS). Tumor evaluations were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 in Study A and RECIST 1.1 in Study B².

References

1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Non-Small Cell Lung Cancer. NCCN 2014 3:1-148.
2. Zykadia® (ceritinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; February 2015.
3. Jemal A, et al. Global cancer statistics. CA Cancer J Clin. 2011;61:69-90.
4. American Cancer Society. Detailed Guide: Lung Cancer (Non-Small Cell). Available at http://www.cancer.org/acs/groups/cid/documents/webcontent/003115-pdf.pdf. Accessed February 2015.
5. Katayama R, Shaw AT, Khan TM, et al. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung cancers. Sci Transl Med. 2012;4(120):1-12.