Adjuvant TAGRISSO: Safety profile was consistent with established profile1

The majority of adverse reactions were Grade 1 or 21

ADVERSE REACTIONS OCCURRING IN ≥10% OF PATIENTS RECEIVING TAGRISSO IN ADAURA*

Adverse reactions occurring in ≥10% of patients receiving TAGRISSO in ADAURA* Adverse reactions occurring in ≥10% of patients receiving TAGRISSO in ADAURA*

No Grade 4 or 5 ARs reported with adjuvant TAGRISSO or placebo among the above mentioned ARs.

In addition, clinically relevant adverse reactions in ADAURA that occurred in <10% of patients receiving TAGRISSO were alopecia (6%), epistaxis (6%), interstitial lung disease (3%), palmar-plantar erythrodysesthesia syndrome (1.8%), urticaria (1.5%), keratitis (0.6%), QTc interval prolongation (0.6%), and erythema multiforme (0.3%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec.

In ADAURA, the discontinuation rate due to adverse reactions was 11% with TAGRISSO.***
Adverse reactions leading to dose reductions occurred in 9% of patients on TAGRISSO1†††

*NCI CTCAE v4.0. All events were Grade 3. Includes diarrhea, colitis, enterocolitis, enteritis. §Includes aphthous ulcer, cheilitis, gingival ulceration, glossitis, tongue ulceration, stomatitis, and mouth ulceration. ||Includes abdominal discomfort, abdominal pain, abdominal lower pain, abdominal upper pain, epigastric discomfort, hepatic pain. Includes rash, rash generalized, rash erythematous, rash macular, rash maculopapular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, dermatitis bullous, dermatitis exfoliative generalized, drug eruption, eczema, eczema asteatotic, lichen planus, skin erosion, pustule. #Includes nail bed disorder, nail bed inflammation, nail bed infection, nail discoloration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia. **Includes dry skin, skin fissures, xerosis, eczema, xeroderma. ††Includes pruritus, pruritus generalized, eyelid pruritus. ‡‡Includes cough, productive cough, upper-airway cough syndrome. §§Includes arthralgia, arthritis, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, and spinal pain. ||||Includes cystitis, urinary tract infection, and urinary tract infection bacterial. ¶¶Includes asthenia, fatigue. ##Includes dizziness, vertigo, and vertigo positional. ***The most frequent adverse reactions leading to discontinuation of TAGRISSO were interstitial lung disease (2.7%) and rash (1.2%). †††The most frequent adverse reactions leading to dose reductions or interruptions were diarrhea (4.5%), stomatitis (3.9%), nail toxicity (1.8%), and rash (1.8%).

The majority of laboratory abnormalities were Grade 1 or 21

LABORATORY ABNORMALITIES WORSENING FROM BASELINE IN ≥20% OF PATIENTS IN ADAURA

Laboratory abnormalities worsening from baseline in ≥20% of patients in ADAURA Laboratory abnormalities worsening from baseline in ≥20% of patients in ADAURA

In addition, the laboratory abnormality in ADAURA that occurred in <20% of patients receiving TAGRISSO was increased blood creatinine (10%).

*NCI CTCAE v4.0.

Based on the number of patients with available follow-up laboratory data.

For the treatment of metastatic EGFRm NSCLC

First-line TAGRISSO: Safety profile in FLAURA

The majority of TAGRISSO adverse reactions were Grade 1 or 21

ADVERSE REACTIONS OCCURRING IN ≥10% OF PATIENTS ON TAGRISSO IN FLAURA TRIAL1*

Adverse reactions occurring in ≥10% of patients on TAGRISSO in FLAURA trial1* Adverse reactions occurring in ≥10% of patients on TAGRISSO in FLAURA trial1*

Clinically relevant adverse reactions in FLAURA in <10% of patients receiving TAGRISSO were alopecia (7%), epistaxis (6%), interstitial lung disease (3.9%), urticaria (2.2%), palmar-plantar erythrodysesthesia syndrome (1.4%), QTc interval prolongation (1.1%), and keratitis (0.4%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec.

Adverse reaction data are based on median duration of therapy of 16.2 months for first-line TAGRISSO and 11.5 months for erlotinib/gefitinib.2

  • 2.9% of patients treated with once-daily TAGRISSO had a dose reduction1

At 3 years, nearly 30% of patients were still being treated with TAGRISSO vs erlotinib/gefitinib3‡‡

RTI, respiratory tract infection. *NCI CTCAE v4.0. One Grade 5 (fatal) event was reported (diarrhea) for EGFR-TKI comparator. Includes stomatitis and mouth ulceration. §Includes rash, rash generalized, rash erythematous, rash macular, rash maculopapular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion, pustule. ||Includes dry skin, skin fissures, xerosis, eczema, xeroderma. Includes nail bed disorder, nail bed inflammation, nail bed infection, nail discoloration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia. #Includes pruritus, pruritus generalized, eyelid pruritus. **Includes fatigue, asthenia. ††Includes prolonged QT interval reported as adverse reaction. ‡‡In the FLAURA trial, treatment beyond the point of disease progression was allowed as long as there was continued clinical benefit, as judged by the investigator.2

The majority of laboratory abnormalities were Grade 1 or 21

LABORATORY ABNORMALITIES WORSENING FROM BASELINE IN ≥20% OF PATIENTS IN FLAURA1

TAGRISSO (n=279) erlotinib/gefitinib (n=277)
Laboratory Abnormality* All grades (%) Grade 3 or 4 (%) All grades (%) Grade 3 or 4 (%)
Hematology
Lymphopenia 63 6 36 4.2
Anemia 59 0.7 47 0.4
Thrombocytopenia 51 0.7 12 0.4
Neutropenia 41 3 10 0
Chemistry
Hyperglycemia 37 0 31 0.5
Hypermagnesemia 30 0.7 11 0.4
Hyponatremia 26 1.1 27 1.5
Increased AST 22 1.1 43 4.1
Increased ALT 21 0.7 52 8
Hypokalemia 16 0.4 22 1.1
Hyperbilirubinemia 14 0 29 1.1

The clinically relevant laboratory abnormality in FLAURA that occurred in <20% of patients receiving TAGRISSO was increased blood creatinine (9%).

*NCI CTCAE v4.0. Each test incidence, except for hyperglycemia, is based on the number of patients who had both baseline and at least one on-study laboratory measurement available (TAGRISSO range: 267-273 and EGFR-TKI comparator range: 256-268). Hyperglycemia is based on the number of patients who had both baseline and at least one on-study laboratory measurement available: TAGRISSO (179) and EGFR-TKI comparator (191).

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ARs, adverse reactions; CTCAE, Common Terminology Criteria for Adverse Events; EGFR, epidermal growth factor receptor; NCI, National Cancer Institute; TKI, tyrosine kinase inhibitor.

References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2021. 2. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125. 3. Ramalingam SS, Vansteenkiste J, Planchard D, et al; FLAURA Investigators. Overall survival with osimertinib in treated, EGFR-mutated advanced NSCLC. N Engl J Med. 2020;382(1):41-50.

Important Safety Information Expand

  • There are no contraindications for TAGRISSO

  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients; 0.3% of cases were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed

  • Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 1479 TAGRISSO-treated patients in clinical trials, 0.8% were found to have a QTc >500 msec, and 3.1% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia

  • Cardiomyopathy occurred in 3% of the 1479 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.2% of 1233 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO

  • Keratitis was reported in 0.7% of 1479 patients treated with TAGRISSO in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist

  • Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed

  • Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity

  • Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose

  • Most common (≥20%) adverse reactions, including laboratory abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough

Indications

  • TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

  • TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

  • TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy


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