PMID- 30030733
OWN - NLM
STAT- MEDLINE
DCOM- 20190611
LR  - 20191210
IS  - 1179-1950 (Electronic)
IS  - 0012-6667 (Linking)
VI  - 78
IP  - 12
DP  - 2018 Aug
TI  - Alectinib: A Review in Advanced, ALK-Positive NSCLC.
PG  - 1247-1257
LID - 10.1007/s40265-018-0952-0 [doi]
AB  - Alectinib (Alecensa((R))) is a potent and highly selective anaplastic lymphoma 
      kinase (ALK) tyrosine kinase inhibitor. Oral alectinib monotherapy is approved in 
      the EU as first-line treatment for adults with advanced ALK-positive non-small 
      cell lung cancer (NSCLC) and for the treatment of adults with advanced 
      ALK-positive NSCLC previously treated with crizotinib. In the USA, alectinib is 
      indicated for the treatment of adults with ALK-positive metastatic NSCLC. The 
      recommended dosage for alectinib in the EU and USA is 600 mg twice daily. 
      Well-designed phase III studies in patients with ALK-positive NSCLC showed that 
      during up to  approximately  19 months' follow-up, progression-free survival (PFS) was 
      significantly improved with alectinib relative to crizotinib as first-line 
      therapy (ALEX study), and relative to chemotherapy in patients previously treated 
      with crizotinib and platinum-doublet chemotherapy (ALUR study). Central nervous 
      system (CNS)-related outcomes were significantly improved with alectinib in both 
      these settings. Two phase II registrational studies (NP28673 and NP28761) in 
      patients previously treated with crizotinib also demonstrated the efficacy of 
      alectinib, as assessed by objective response rates (ORRs), during up to 
      21 months' follow-up. Overall, alectinib had a manageable tolerability profile in 
      these settings, with most adverse events (AEs) of mild or moderate severity. 
      Current evidence indicates that alectinib is an important treatment option for 
      patients with advanced ALK-positive NSCLC who are previously untreated or those 
      previously treated with crizotinib. Given its efficacy and tolerability, current 
      guidelines include alectinib as a treatment option in these settings, with the 
      NCCN guidelines recommending it as a preferred option for first-line therapy.
FAU - Paik, Julia
AU  - Paik J
AD  - Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. 
      demail@springer.com.
FAU - Dhillon, Sohita
AU  - Dhillon S
AD  - Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - New Zealand
TA  - Drugs
JT  - Drugs
JID - 7600076
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Carbazoles)
RN  - 0 (Piperidines)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.1 (Anaplastic Lymphoma Kinase)
RN  - LIJ4CT1Z3Y (alectinib)
SB  - IM
MH  - Administration, Oral
MH  - Anaplastic Lymphoma Kinase/*antagonists & inhibitors
MH  - Antineoplastic Agents/pharmacokinetics/pharmacology/*therapeutic use
MH  - Carbazoles/pharmacokinetics/pharmacology/*therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/enzymology
MH  - Clinical Trials as Topic
MH  - Drug Approval
MH  - Drug Resistance, Neoplasm
MH  - Europe
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/enzymology
MH  - Piperidines/pharmacokinetics/pharmacology/*therapeutic use
MH  - Protein Kinase Inhibitors/pharmacokinetics/pharmacology/*therapeutic use
MH  - Treatment Outcome
EDAT- 2018/07/22 06:00
MHDA- 2019/06/14 06:00
CRDT- 2018/07/22 06:00
PHST- 2018/07/22 06:00 [pubmed]
PHST- 2019/06/14 06:00 [medline]
PHST- 2018/07/22 06:00 [entrez]
AID - 10.1007/s40265-018-0952-0 [pii]
AID - 10.1007/s40265-018-0952-0 [doi]
PST - ppublish
SO  - Drugs. 2018 Aug;78(12):1247-1257. doi: 10.1007/s40265-018-0952-0.