First-Line Efficacy

ALECENSA® (alectinib) More Than Doubled mPFS vs Crizotinib

ALECENSA reduced the risk of progression or death by 47% 1


IRC- Assessed PFS ALECENSA® (alectinib) IRC- Assessed PFS ALECENSA® (alectinib)

Median duration of follow-up 8

  • ALECENSA 18.6 months; crizotinib 17.6 months

Patients with event 1:

  • ALECENSA 41% (n=63); crizotinib 61% (n=92)

ORR 1:

  • ALECENSA 79% (95% CIb: 72, 85); crizotinib 72% (95% CIb: 64, 79); P=0.1652a

Investigator-assessed PFS 1:

  • Results were similar to that observed by IRC
    • HR=0.48 (95% CI: 0.35, 0.66); P<0.0001
a Stratified by race (Asian vs non-Asian) and CNS metastases at baseline (yes vs no) for Cox model, log-rank test, and Cochran Mantel-Haenszel test, respectively.
b Clopper and Pearson exact binomial 95% CI.

ALECENSA Significantly Reduced the Risk of CNS as the First Site of Progression

ALK+ mNSCLC Has a Propensity to Metastasize to the Brain 8

Time to Cause-Specific CNS Progression 1,8,10,11

  • The efficacy of ALECENSA was evaluated in delaying or preventing tumors spreading to or growing in the CNS as the first site of progression (alone or with concurrent systemic progression)
    • This analysis was conducted to separate the effect of ALECENSA on CNS progression from systemic progression or death
    • Patients who first progressed systemically, and patients with death prior to CNS or systemic progression (ALECENSA n=47; crizotinib n=42)c, were not included as events



ALECENSA® (alectinib) Time to CNS Progression ALECENSA® (alectinib) Time to CNS Progression
  • Fewer patients progressed in the CNS when treated with ALECENSA (n=18/152, 12%) vs crizotinib (n=68/151, 45%) 1
c Systemic progression without prior CNS progression (ALECENSA n=36; crizotinib n=33); death prior to CNS or systemic progression (ALECENSA n=11; crizotinib n=9).
d Cause-specific hazard ratios and 95% CI were estimated by Cox model where patients with competing events (systemic progression, death prior to CNS, or systemic progression) were censored at the time of these events. P-values were estimated from two-sided stratified cause-specific log-rank tests. 10

Higher CNS Response Rates Observed With ALECENSA vs Crizotinib


Exploratory Endpoint ALECENSA


CNS ORR, % (95% CI e)
  • 81% (58, 95)
  • 50% (28, 72)
  • 38%
  • 5%
  • 59% of patients (n=17) experienced a CNS response lasting ≥12 months with ALECENSA vs 36% of patients (n=11) with crizotinib 1
  • Percentage of patients with prior CNS radiation: 17% with ALECENSA (n=26/152) vs 14% with crizotinib (n=21/151) 8

eClopper and Pearson exact binomial 95% CI.

* The National Comprehensive Cancer Network® (NCCN®) makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

CI=confidence interval; CNS=central nervous system; CR=complete response; HR=hazard ratio; IRC=Independent Review Committee; mPFS=median progression-free survival; NR=not reached; ORR=objective response rate; PFS=progression-free survival.

NCCN Recommendation


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Important Safety Information & Indication


ALECENSA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (mNSCLC) as detected by an FDA-approved test.

Warnings and Precautions


  • Of 405 patients, elevations of AST >5X the upper limit of normal (ULN) occurred in 4.6% of patients, and elevations of ALT >5X the ULN occurred in 5.3% of patients. Elevations of bilirubin >3X the ULN occurred in 3.7% of patients. The majority (69% of the patients with hepatic transaminase elevations and 68% of the patients with bilirubin elevations) of these events occurred during the first 3 months of treatment. Six patients discontinued ALECENSA for Grades 3-4 AST and/or ALT elevations, and 4 patients discontinued ALECENSA for Grade 3 bilirubin elevations. Concurrent elevations in ALT or AST ≥3X the ULN and total bilirubin ≥2X the ULN, with normal alkaline phosphatase, occurred in <1% of patients treated with ALECENSA across clinical trials. Three patients with Grades 3-4 AST/ALT elevations had drug-induced liver injury (2 documented by liver biopsy)
  • Monitor liver function tests including ALT, AST, and total bilirubin every 2 weeks during the first 3 months of treatment, then once a month and as clinically indicated, with more frequent testing in patients who develop transaminase and bilirubin elevations. Based on the severity of the adverse drug reaction, withhold ALECENSA and resume at a reduced dose, or permanently discontinue ALECENSA

Interstitial Lung Disease (ILD)/Pneumonitis

  • ILD/pneumonitis occurred in 3 (0.7%) patients treated with ALECENSA. One (0.2%) of these events was severe (Grade 3)
  • Promptly investigate for ILD/pneumonitis in any patient who presents with worsening of respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever)
  • Immediately withhold ALECENSA treatment in patients diagnosed with ILD/pneumonitis and permanently discontinue ALECENSA if no other potential causes of ILD/pneumonitis have been identified

Renal Impairment

  • Renal impairment occurred in 8% of patients. The incidence of Grade ≥3 renal impairment was 1.7%, of which 0.5% were fatal events
  • Dose modifications for renal impairment were required in 3.2% of patients. Median time to Grade ≥3 renal impairment was 3.7 months (range 0.5 to 14.7 months)
  • Permanently discontinue ALECENSA for Grade 4 renal toxicity. Withhold ALECENSA for Grade 3 renal toxicity until recovery to ≤1.5X ULN, then resume at reduced dose


  • Symptomatic bradycardia can occur with ALECENSA. Cases of bradycardia (8.6%) have been reported in patients treated with ALECENSA. Eighteen percent of 365 patients treated with ALECENSA for whom serial ECGs were available had heart rates of <50 beats per minute (bpm)
  • Monitor heart rate and blood pressure regularly. Dose modification is not required in cases of asymptomatic bradycardia. In cases of symptomatic bradycardia that are not life-threatening, withhold ALECENSA until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm and evaluate concomitant medications known to cause bradycardia, as well as anti-hypertensive medications. If attributable to a concomitant medication, resume ALECENSA at a reduced dose upon recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, with frequent monitoring as clinically indicated. Permanently discontinue ALECENSA in case of recurrence. Permanently discontinue ALECENSA in cases of life-threatening bradycardia if no contributing concomitant medication is identified

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation

  • Myalgia or musculoskeletal pain occurred in 26% of patients. The incidence of Grade 3 myalgia/musculoskeletal pain was 0.7%. Dose modifications for myalgia/musculoskeletal pain were required in 0.5% of patients
  • Elevations of CPK occurred in 41% of 347 patients with CPK laboratory data. The incidence of Grade 3 elevations of CPK was 4.0%. Median time to Grade 3 CPK elevation was 14 days (interquartile range 13-28 days). Dose modifications for elevation of CPK occurred in 3.2% of patients
  • Advise patients to report any unexplained muscle pain, tenderness, or weakness. Assess CPK levels every 2 weeks for the first month of treatment and as clinically indicated in patients reporting symptoms. Based on the severity of the CPK elevation, withhold ALECENSA, then resume or reduce dose

Embryo-Fetal Toxicity

  • Based on findings from animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to pregnant women. Administration of ALECENSA to pregnant rats and rabbits during the period of organogenesis resulted in embryo-fetal toxicity and abortion at maternally toxic doses with exposures approximately 2.7X those observed in humans with ALECENSA 600 mg twice daily. Advise pregnant women of the potential risk to a fetus
  • Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week following the final dose

Most Common Adverse Reactions

  • The most common adverse reactions (incidence ≥20%) were constipation (34%), fatigue (26%), edema (22%), myalgia (23%), and anemia (20%)

Use in Specific Populations


  • Based on animal studies and its mechanism of action, ALECENSA can cause fetal harm when administered to a pregnant woman. There are no available data on ALECENSA use in pregnant women
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively


  • Because of the potential for serious adverse reactions in breastfed infants from ALECENSA, advise a lactating woman not to breastfeed during treatment with ALECENSA and for 1 week after final dose

Females and Males of Reproductive Potential

  • ALECENSA can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ALECENSA and for 1 week after the final dose
  • Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with ALECENSA and for 3 months following the final dose

Hepatic Impairment

  • Increased exposure of alectinib occurred in patients with severe hepatic impairment (Child-Pugh C). The recommended dose of ALECENSA in patients with severe hepatic impairment (Child-Pugh C) is 450 mg orally twice daily

Patient Counseling Information


  • Inform patients of the signs and symptoms of photosensitivity. Advise patients to avoid prolonged sun exposure while taking ALECENSA and for at least 7 days after discontinuation and to use proper protection from the sun. Advise patients to use a broad spectrum ultraviolet A (UVA)/ultraviolet B (UVB) sunscreen and lip balm (SPF ≥50) to help protect against potential sunburn

You may report side effects to the FDA at 1-800-FDA-1088 or You may also report side effects to Genentech at 1-888-835-2555.

Please see additional Important Safety Information in full Prescribing Information.