Prescribing Information | Indication
Important Safety Information
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NEW
FLAURA2 trial results:
Data that can change the conversation


	Dear Healthcare Professional,

	The latest FLAURA2 results are out! See the updated data for TAGRISSO + CT (pem/plat).

	TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.1

	Please see Important Safety Information below and complete Prescribing Information, including Patient Information.

In first-line locally advanced or
metastatic EGFRm NSCLC

Longest reported mPFS and mOS with TAGRISSO + chemotherapy*

PRIMARY ENDPOINT (INVESTIGATOR‑ASSESSED MEDIAN PFS)

25.5 months (95% Cl: 24.7, NE) for TAGRISSO + CT (pem/plat)† vs 16.7 months (95% Cl: 14.1, 21.3) for TAGRISSO;
HR=0.62 (95% Cl: 0.49, 0.79); P<0.0001; N=5571‡

OVERALL SURVIVAL DATA (SECONDARY ENDPOINT)

median overall survival§

47.5 months (95% CI: 41.0, NC) for TAGRISSO + CT (pem/plat)† vs 37.6 months (95% CI: 33.2, 43.2) for TAGRISSO2

STATISTICALLY SIGNIFICANT OVERALL SURVIVAL2

STATISTICALLY SIGNIFICANT OVERALL SURVIVAL DATA

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OS rates at 24, 36, and 48 months were not powered to show statistical significance

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Median follow-up for OS (censored patients): 51.2 months (0.2, 60.4) for TAGRISSO + CT (pem/plat) and 51.3 months (0.1, 60.1) for TAGRISSO

*	TAGRISSO + chemotherapy reported the longest statistically significant mOS of an FDA-approved regimen for 1L treatment of patients with EGFRm (exon 19 or exon 21 L858R) locally advanced or metastatic NSCLC.1,2
†	TAGRISSO + CT (pem/plat) dosing: In cycles 1-4, TAGRISSO 80 mg po qd + pemetrexed (500 mg/m2) q3w + cisplatin (75 mg/m2) or carboplatin (AUC 5) q3w; in cycles 5+, TAGRISSO 80 mg po qd + pemetrexed maintenance (500 mg/m2) q3w until disease progression or unacceptable toxicity. TAGRISSO dosing: 80 mg po qd until disease progression or unacceptable toxicity.1
‡	Overall PFS maturity by IA was 51%.3
§	Overall OS maturity was 57%.2

CT (pem/plat), pemetrexed plus platinum-based chemotherapy.

Could your eligible patients benefit from TAGRISSO + CT (pem/plat)?

LEARN MORE

IMPORTANT SAFETY INFORMATION

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There are no contraindications for TAGRISSO

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TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy (CRT); 0.4% of cases were fatal. In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal. For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed

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TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% 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

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TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO

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Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy 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

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

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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

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Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated

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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 last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose

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Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose

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Most common (≥20%) adverse reactions, including laboratory abnormalities, were:

–	TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine

INDICATION


•	TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test

Please see complete Prescribing Information, including Patient Information for TAGRISSO.

You may report side effects related to AstraZeneca products .

1L, first-line; AUC, area under the curve; CI, confidence interval; CT (pem/plat), pemetrexed plus platinum-based chemotherapy; EGFRm, epidermal growth factor receptor mutation; FDA, US Food and Drug Administration; HR, hazard ratio; IA, investigator assessment; L858R, exon 21 leucine 858 arginine substitution; mOS, median overall survival; mPFS, median progression-free survival; NC, not calculable; NE, not estimable; NSCLC, non-small cell lung cancer; OS, overall survival; PFS, progression-free survival; po, by mouth; q3w, once every 3 weeks; qd, once daily.

References: 1. TAGRISSO [package insert]. ‌Wil‌min‌gt‌on,‌ D‌E:‌ AstraZeneca Pharmaceuticals L‌P; ‌2‌0‌2‌4‌. 2. Planchard D, Jänne PA, Kobayashi K, et al. First-line osimertinib + chemotherapy versus osimertinib monotherapy in EGFRm advanced NSCLC: FLAURA2 final overall survival [oral presentation]. Presented at: World Conference on Lung Cancer; S‌e‌p‌t‌e‌m‌b‌e‌r 6‌‑9, ‌2‌0‌2‌5‌; Barcelona, Spain. 3. Planchard D, Jänne PA, Cheng Y, et al; FLAURA2 Investigators. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med. 2023;389(21):1935-1948.

This product information is intended for US Healthcare Professionals only.

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TAGRISSO is a registered trademark of the AstraZeneca group of companies.

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