ALECENSA® (alectinib) Has a Well-Established Safety Profile

Overall fewer Grade 3-4 adverse reactions occurred with ALECENSA compared with crizotinib 1

Adverse Drug Reactions (>10% for all NCI CTCAE Grades or ≥2% for Grades 3-4) in Patients Treated With ALECENSA or Crizotinib 1

aIncludes fatigue and asthenia. bIncludes peripheral edema, edema, eyelid edema, localized edema, and face edema. cIncludes myalgia and musculoskeletal pain. dIncludes rash, rash maculopapular, dermatitis acneiform, erythema, generalized rash, rash macular, rash papular, exfoliative rash, and pruritic rash. eIncludes dysgeusia and hypogeusia. fIncludes blurred vision, visual impairment, vitreous floaters, reduced visual acuity, and diplopia. gIncludes reported cases of bradycardia and sinus bradycardia but is not based on serial ECG assessment. hIncludes increased blood creatinine, creatinine renal clearance decreased, glomerular filtration rate decreased, and acute kidney injury. iIncludes 2 Grade 5 events.

Fewer dose reductions, interruptions, and discontinuations due to adverse reactions occurred with ALECENSA vs crizotinib 1,2

Safety Overview in Primary Analysis 1,2

jAll unrelated to treatment. 2 
kTwo related to treatment. 2

Most frequent adverse reactions (≥2%) leading to a dose modification for ALECENSA 3

  • Dose reduction: elevated ALT (2%), elevated AST (3.3%), elevated bilirubin (2%), anemia (2%), and hyperbilirubinemia (2%)
  • Dose interruption: ALT increased (3%) and AST increased (2%)
  • Permanent discontinuation: renal impairment (2%)

Laboratory Abnormalities Occurring in >10% of Patients Treated With ALECENSA or Crizotinib 1l

Note: Based on NCI CTCAE v4.03. Excludes patients with no post-baseline lab assessments.

lPatients with missing baseline values were included. For each laboratory abnormality, the number of patients evaluated may vary (n=131 to n=148). Please refer to PI for additional information. 1

Consistent Safety Profile Observed at Follow-Up 1,2,14

Safety Overview in Follow-Up Analysis 14

jAll unrelated to treatment. 18
kTwo related to treatment. 18

1L=first-line; ALT=alanine transaminase; AST=aspartate transaminase; CNS=central nervous system; CPK=creatine phosphokinase; ECG=electrocardiogram; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; PFS=progression-free survival.

1L PFS Results

View PFS results vs crizotinib from the head-to-head ALEX trial.

CNS Efficacy in 1L ALK+ mNSCLC

Learn more about CNS efficacy with ALECENSA.

Dosing and Administration

Learn about dosing and monitoring for ALECENSA.