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Association details:
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Title:

Ensartinib Secured Its First Approval for 1st Line Treatment in ALK+ NSCLC

Excerpt:
...Xcovery Holdings, Inc... announced that Xcovery’s affiliate Betta Pharmaceuticals has received the National Medical Products Administration (NMPA)’s approval of ensartinib in China for the first-line treatment of ALK-positive non-small cell lung cancer (NSCLC).
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial

Excerpt:
We did a single-arm, open-label, phase 2 study at 27 centres in China. Patients were aged 18 years or older, had stage IIIb or stage IV ALK-positive NSCLC that had progressed while they were on crizotinib therapy...All patients received 225 mg ensartinib...76 (52% [95% CI 43-60]) of 147 patients in the full analysis set, with responses that could be assessed by the independent review committee, had an objective response. 28 (70% [53-83]) of 40 patients with measurable brain metastases as assessed by the independent review committee had an intracranial objective response.
DOI:
10.1016/S2213-2600(19)30252-8
Trial ID: