This article has been updated with additional information about the availability of an FDA-approved companion diagnostic for Zykadia. Roche announced FDA approved its Ventana ALK (D5F3) test on June 1.
NEW YORK (GenomeWeb) – The US Food and Drug Administration today approved an expanded indication for Novartis' Zykadia (ceritinib), making it a first-line option for metastatic non-small cell lung cancer patients with ALK rearrangements.
The updated indication allows NSCLC patients whose cancer has spread to the brain to also receive the drug.
"An FDA-approved test at the time of diagnosis may help to determine the presence of this mutation and, thus, the most appropriate treatment option," Novartis said in a statement. However, in a release announcing the approval, the drugmaker didn't identify the FDA-approved companion diagnostic.
A Novartis spokesperson said that the drugmaker collaborated with Roche on a companion diagnostic, and is awaiting FDA approval of its Ventana ALK (D5F3) assay.
The agency previously granted accelerated approval to Zykadia in 2014 for metastatic, ALK-positive NSCLC patients who had stopped responding to Pfizer's ALK inhibitor Xalkori (crizotinib). The FDA approved Xalkori in 2011 alongside Abbott Molecular's Vysis ALK Break Apart Fluorescence In Situ Hybridization Probe Kit as a companion diagnostic.
However, with the initial accelerated approval for Zykadia, the agency did not approve a companion diagnostic since patients would only receive it after getting on Xalkori, and would have already had their ALK status determined.
In order to receive the updated indication, Novartis submitted data from the Phase III ASCEND-4 study, and showed that Zykadia-treated patients had a median progression-free survival of 16.6 months, compared to 8.1 months for those receiving a platinum-based chemotherapy regimen. Overall intracranial response rate in patients with measurable brain metastases was 57 percent on Zykadia versus 22 percent on chemotherapy.
All 376 patients in this study had to have tumors with an ALK-rearrangement identified by the Ventana ALK (D5F3) test, according to an FDA announcement.