- Novartis announced Friday that the Food and Drug Administration has approved the expanded use of Zykadia (ceritinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive.
- The drug had previously been approved for ALK-positive NSCLC patients who progressed or were intolerant to crizotinib, and as a first-line treatment for metastatic ALK-positive NSCLC patients with metastases to the brain.
- The FDA’s thumbs up follows the label expansion for Zykadia last week by a committee from the European Medicine’s Agency for the same indication.
The FDA approval has helped secure Novartis’ position in a relatively small market, but one that has begun to heat up this month. NSCLC patients who have the anaplastic lymphoma kinase mutation (ALK) can now receive initial treatment with the targeted therapies Zykadia and Pfizer’s Xalkori (crizotinib), the current standard of care.
In early May, Takeda Pharmaceutical also secured FDA approval for Alunbrig (brigatinib) for second-line treatment of ALK-positive NSCLC patients. Takeda is also targeting first-line FDA approval of Alunbrig with a Phase 3 trial pitting the drug against Xalkori. The trial aims to enroll 270 patients, and is expected to readout in 2019.
Roche’s Alecensa (alectinib) is also approved for second-line treatment of ALK-positive NSCLC, which makes up 5% of the NSCLC population. The company recently unveiled results from a late-stage trial showing the Alecensa outperformed Xalkori in previously treated ALK-positive NSCLC patients.
The first-line FDA approval of Zykadia was based upon results from the open-label randomized, multi-center, global Phase 3 trial, ASCEND-4. In the trial, 189 patients with stage IIIB or IV ALK-positive advanced NSCLC treated with Zykadia had a median progression-free survival (PFS) of 16.6 months. By contrast, the PFS was 8.1 months for 187 patients treated with standard first-line platinum chemotherapy.
The study’s results also revealed that the overall intracranial response rate among patients with measurable brain metastases was 57% compared to 22% for those treated with chemotherapy. The overall response rate among all patients treated with Zykadia in the study was 73% while the ORR among chemotherapy patients in the trial was 27%.