New FDA Approval for Zykadia (ceritinib) for ALK-Positive NSCLC: Why I Think It's a Poor Choice for Initial Treatment

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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. .

Should Alecensa (Alectinib) be the new first line ALK inhibitor for ALK-positive NSCLC?

Article

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.

Clinical Trial Spotlight: Should a Second Generation ALK Inhibitor be First Line Therapy for Patients with ALK-Positive NSCLC?

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Dr. Jack West asks the question of whether newer, more active ALK inhibitors such as alectinib should be used as first line therapy rather than for acquired resistance, including introducing the ALEX trial that is trying to answer this question.

My Top Five Highlights in Lung Cancer from 2014

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An annual tradition is a reflection on the key developments in the field over the past year. This year saw some major advances, with several of the biggest changes bubbling just below the surface and about to really break out in 2015.  So without further adieu, here's my list.

For those who wish to access the pdf, it's here: Top 5 Highlights in Lung Cancer 2014

Agree? Disagree? What's highest on your wish list for 2015?