December 17, 2017 at 3:25 pm #1293645
New FDA Approval for Zykadia (ceritinib) for ALK-Positive NSCLC: Why I Think It's a Poor Choice for Initial Treatment
The FDA just approved a new therapy for the approximately 4% of patients with NSCLC who have the molecular marker known as an ALK rearrangement. The agent Zykadia (ceritinib), a "second generation" ALK inhibitor that is more effective than Xalkori (crizotinib) in lab models of ALK-positive NSCLC, and the new approval was for Zykadia as first line treatment for ALK-positive lung cancer, a setting where we have historically favored Xalkori since it was approved in 2011. .
New and first time post. Wife diagnosed nsclc 7/2012 stage 4 ALK mutation. Now 57 never smoker and active exerciser. Full 6 treatments carbo/alimta and 1plus year alimta maintenance. Crizotinib about a year forced to ceritinib due to more than 25 brain mets and balnce issues. also at same time, whole brain radiation in 10/2015 mistake??? Brain mets size reduced and stable as of 6/2016. Was it radiation or ceritinib?? Bone mets in shoulder 2/2016 and palliative rad.
Probably the most immediate potentially practice-changing presentation from ASCO was the Japanese J-ALEX study in the subset of about 4-5% of patients with non-small cell lung cancer (NSCLC) who have the molecular driver known as an anaplastic lymphoma kinase (ALK) rearrangement, which we now routinely test for from the tumor tissue of patients with a non-squamous metastatic NSCLC.
Dr. Ross Camidge, University of Colorado, addresses the question of whether to use a second generation ALK inhibitor as first line therapy or only after acquired resistance to crizotinib.
Dr. Ross Camidge, University of Colorado, discusses management of CNS progression for ALK-positive NSCLC including monitoring frequency and preferences between systemic and radiation therapy.
Dr. Ross Camidge, University of Colorado, describes the second generation ALK-inhibitors which provide good options for ALK-positive NSCLC patients who have developed acquired resistance to crizotinib.
Dr. Ross Camidge, University of Colorado, explains the preference for crizotinib rather than platinum doublet chemotherapy as first line treatment for patients with ALK or ROS1 rearrangements.
Dr. Ross Camidge, University of Colorado, describes ROS-1 rearrangements and compares them to ALK rearrangements in frequency of occurrence and response to treatment.
Dr. Heather Wakelee, Stanford University Medical Center, evaluates the lack of evidence for the use of targeted therapies after surgery, and describes ongoing trials attempting to resolve that issue.