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The importance of Next Generation Sequencing (NGS)

 

  • 70% of mNSCLC patients have an identifiable oncogenic mutation

  • More than 1 in 4 patients with advanced or metastatic NSCLC have an actionable oncogenic driver mutation with an associated FDA-approved targeted therapy

  • METex14 mutation testing using a broad multi-gene panel is a critical component of NSCLC management

Complete genomic profiling with a next-generation sequencing (NGS) is critical to determining the appropriate treatment approach and improve clinical outcomes

 

Increasing the number of patients tested with NGS vs single-gene testing could result in cost savings for the system and the patient

 

  • Doubling the number of patients tested with NGS from 25% to 50% has resulted in a greater than 10x CMS cost savings CMS for commercial payers

  • Cost savings was seen when comparing use of NGS across various testing methods, including:

    • Exclusionary testing

    • Hotspot testing

    • Sequential testing

Indication

TABRECTA is a kinase inhibitor indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a mesenchymal-epithelial transition (MET) exon 14 skipping mutation as detected by an FDA-approved test

Important Safety Information

Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, has occurred in patients treated with TABRECTA. Any Grade ILD/pneumonitis was reported in 15 of 334 patients (4.5%) treated with TABRECTA in GEOMETRY-mono 1. Grade 3 ILD/pneumonitis was reported in 6 patients (1.8%), with a fatal event of pneumonitis reported in 1 patient (0.3%). ILD/pneumonitis occurred in 8 of 161 patients (5.0%) with a history of prior radiotherapy and 7 of 173 patients (4.0%) who did not receive prior radiotherapy.

Promptly investigate in any patient with worsening of pulmonary symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold TABRECTA in patients with suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified

Hepatic Effects Transaminase elevations have occurred in patients treated with TABRECTA. Any Grade alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevations were reported in 43 of 334 patients (13%) treated with TABRECTA in GEOMETRY-mono 1. Grade 3/4 ALT/AST elevations were observed in 19 of 334 patients (6%) treated with TABRECTA.

Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of treatment, every 2 weeks during the first 3 months of treatment, then once a month or as clinically indicated, with more frequent testing in patients who develop transaminase or bilirubin elevations. Based on the severity of the adverse reaction, temporarily withhold, dose reduce, or permanently discontinue TABRECTA as described in Table 2

Embryo-Fetal Toxicity. Based on findings from animal studies and its mechanism of action, TABRECTA can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus if TABRECTA is used during pregnancy or if the patient becomes pregnant while taking TABRECTA. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for at least 7 days after the last dose. Advise male patients with female partners of reproductive potential to use condoms during treatment with TABRECTA and for at least 7 days after the last dose.

Photosensitivity. Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA. Advise patients to minimize exposure to sunlight and artificial ultraviolet (UV) light while taking TABRECTA.

Most Common Adverse Reactions. In the GEOMETRY-mono 1 study, the most common adverse reactions (≥10%) were peripheral edema (52%), nausea (44%), fatigue (32%), vomiting (28%), dyspnea (24%), decreased appetite (21%), diarrhea (18%), constipation (18%), cough (16%), non-cardiac chest pain (15%), pyrexia (14%), back pain (14%), and weight decreased (10%). In the GEOMETRY-mono 1 study, the most common grade 3 adverse reactions (≥2%) were peripheral edema (9%), fatigue (8%), dyspnea (6%), nausea (2.7%), vomiting (2.4%) and non-cardiac chest pain (2.1%).

Other Clinically Important Adverse Reactions. In the GEOMETRY-mono 1 study, other clinically important adverse reactions observed in <10% of patients were pruritus, ILD/pneumonitis, cellulitis, acute kidney injury including renal failure, urticaria, and acute pancreatitis.

Laboratory Abnormalities. In the GEOMETRY-mono 1 study, treatment-emergent laboratory abnormalities occurring in ≥4% for Grades 3-4 were decreased lymphocytes (57%), increased gamma-glutamyltransferase (47%), increased alanine aminotransferase (ALT) (38%), increased amylase (36%), increased aspartate aminotransferase (AST) (28%), increased lipase (27%), decreased sodium (25%), and decreased phosphate (24%).

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