European Union - English - EMA (European Medicines Agency)

roche registration gmbh - alectinib hydrochloride - carcinoma, non-small-cell lung - antineoplastic agents - alecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (alk)-positive advanced non-small cell lung cancer (nsclc).alecensa as monotherapy is indicated for the treatment of adult patients with alk‑positive advanced nsclc previously treated with crizotinib.

Singapore - English - HSA (Health Sciences Authority)

abbott laboratories (singapore ) private limited - pathology - the vysis alk break apart fish probe kit is a qualitative test to detect rearrangements involving the alk gene via fluorescence in situ hybridization (fish) in formalin-fixed paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissue specimens to aid in identifying those patients eligible for treatment with xalkori®(crizotinib). the test is for prescription use only.

Singapore - English - HSA (Health Sciences Authority)

roche diagnostics asia pacific pte ltd - pathology - ventana anti-alk (d5f3) rabbit monoclonal primary antibody (ventana anti-alk (d5f3)) is intended for laboratory use in the detection of the anaplastic lymphoma kinase (alk) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (nsclc) tissue stained with the benchmark ihc/ish instruments. it is indicated as an aid in identifying patients eligible for treatment with xalkori® (crizotinib), zykadia® (ceritinib), or alecensa® (alectinib). this product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. this antibody is intended for in vitro diagnostic (ivd) use.