Novartis zykadia is approved for first-line treatment of ALK positive non-small cell lung cancer

Source: Wuxi apptec Co., Ltd announced recently that FDA approved to expand the use of zykadia (ceritinib) in the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients These patients were confirmed to be positive for anaplastic lymphoma kallidinogenase (ALK) by FDA approved testing methods Zykadia was first approved accelerated in 2014 for the treatment of ALK positive metastatic NSCLC, and their disease progression or intolerance to crizotinib In January 2017, FDA issued the breakthrough therapy design for zykadia, which was used to treat brain metastatic NSCLC patients with ALK positive first-line treatment, and also issued the priority review qualification to the first-line treatment of ALK positive metastatic NSCLC About 3-7% of NSCLC patients have ALK gene rearrangement, and FDA approved detection methods may help to determine the existence of this mutation during diagnosis, thus helping to determine the most appropriate treatment plan The approval of zykadia's first-line therapy is based on the results of an open label, randomized, multicenter, global phase 3 trial, ascend-4 The patients were treated with zykadia or pemetrexed platinum dual dose chemotherapy (500mg / m2 pemetrexed plus 75mg / m2 cisplatin or carboplatin AUC 5-6) for four cycles every day, and then continued to use pemetrexed maintenance therapy The median progression free survival (PFS) was 16.6 months (95% confidence interval [CI]: 12.6, 27.2) in the first-line zykadia group, but only 8.1 months (95% CI: 5.8, 11.1) in the maintenance group Compared with the chemotherapy group, the risk of PFS in the zykadia group was reduced by 45% (risk ratio [HR] = 0.55 [95% CI: 0.42, 0.73; unilateral p value < 0.0001]) For patients treated with zykadia, the overall intracranial remission rate (oirr) was 57% (95% CI: 37, 76; n = 28) for patients with measurable brain metastasis, compared with 22% (95% CI: 9, 42; n = 27) for patients treated with chemotherapy The overall response rate (ORR) of patients treated with zykadia was 73% (95% CI: 66, 79; n = 187) Mr Bruno strigini, CEO of Novartis oncology, said: "this approval is the next step in the development of zykadia as a treatment for ALK positive metastatic NSCLC, which can bring this important drug to the patients who still need it At Novartis, we are committed to developing new drugs for the treatment of lung cancer The first-line approval of zykadia for ALK positive metastatic NSCLC demonstrates our commitment to cancer patients "