Last reviewed 2026-05-13 · How we verify

Alecensa (alectinib)

Alecensa blocks the activity of the ALK protein, which is involved in the growth and spread of cancer cells.

Alecensa (alectinib) is a small molecule kinase inhibitor developed by Hoffmann-La Roche, targeting the ALK tyrosine kinase receptor. It is approved for the treatment of anaplastic lymphoma kinase positive anaplastic large cell lymphoma and non-small cell lung cancer. Alecensa works by blocking the activity of the ALK protein, which is involved in the growth and spread of cancer cells. The drug is patented and has not yet gone off-patent. Key safety considerations include its potential to cause liver damage and other side effects.

At a glance

Mechanism of action

Alectinib is tyrosine kinase inhibitor that targets ALK and RET. In nonclinical studies, alectinib inhibited ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, and decreased tumor cell viability in multiple cell lines harboring ALK fusions, amplifications, or activating mutations. The major active metabolite of alectinib, M4, showed similar in vitro potency and activity.Alectinib and M4 demonstrated in vitro and in vivo activity against multiple mutant forms of the ALK enzyme, including some mutations identified in NSCLC tumors in patients who have progressed on crizotinib. In mouse models implanted with tumors carrying ALK fusions, administration of alectinib resulted in antitumor activity and prolonged survival, including in mouse models implanted intracranially with ALK-driven tumor cell lines.

Approved indications

• Anaplastic lymphoma kinase positive anaplastic large cell lymphoma
• Non-small cell lung cancer

Common side effects

• Renal impairment
• Fatigue
• Edema
• Myalgia
• Pneumonia
• Nausea
• Diarrhea
• Vomiting
• Hyperbilirubinemia
• Increased ALT
• Increased AST
• Rash

Key clinical trials

• A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) (PHASE1,PHASE2)
• Pharmacogenomics ANDA 221517 SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms (PHASE2,PHASE3)
• Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC (PHASE3)
• Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (PHASE2)
• Alectinib in Combination With Nivolumab in the Treatment of Recurrent or Refractory HCC Patients Guided With Serum RNase1 and Tumor Expression of PD-L1 (PHASE1)
• A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) (PHASE3)
• Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements (PHASE1,PHASE2)
• A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) (PHASE2,PHASE3)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Alecensa CI brief — competitive landscape report
• Alecensa updates RSS · CI watch RSS
• Hoffmann-La Roche portfolio CI