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For more information on TABRECTATM (capmatinib) 150 mg, 200 mg tablets, please visit www.hcp.novartis.com/products/tabrecta/.

 

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The biology of METex14 in mNSCLC

 

FAQs

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No. Novartis does not provide any METex14 CDx testing patient support programs. For information about Foundation Medicine billing and reimbursement services, including financial assistance options, customers may call Foundation Medicine at 1-888-988-3639 or visit https://www.foundationmedicine.com/patients#financial-support.

Uninsured patients or patients who are concerned with out-of-pocket costs may apply for financial assistance through Foundation Medicine’s financial assistance program. Patients may apply to the Foundation Medicine financial assistance program by calling 1-888-988-3639 or by visiting their patient website at https://www.foundationmedicine.com/patients#financial-support.

A companion diagnostic is a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product. The test helps a health care professional determine whether a particular therapeutic product’s benefits to patients will outweigh any potential serious side effects or risks.

Foundation Medicine describes FoundationOne®CDx as a comprehensive genomic profiling (CGP) test. A CGP test uses next-generation sequencing (NGS) for the detection of substitutions, insertions and deletions, and copy number alterations as well as genome-wide biomarkers such as microsatellite instable (MSI) or tumor mutational burden (TMB) from tumor specimens. If a customer has further questions, they may visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.

NGS means next-generation sequencing.

  • Next-generation sequencing is defined as technology allowing one to determine the sequence of a DNA molecule, or DNA molecules, in a single test run.

METex14 is an abbreviation for “MET exon 14 skipping.” 

FoundationOne®CDx is clinically validated as a CDx to identify METex14.

To learn more about FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.

For questions about the FDA-approved FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.

For questions about the FDA-approved FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.

The Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination (NCD) for qualifying patients who receive NGS with FDA-approved tests including FoundationOne®CDx.

For questions about the FDA-approved FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.

METex14 is an oncogenic driver and knowledge of METex14 status can inform up-front treatment planning.

METex14 is present in ~3% of patients with mNSCLC. Patients with METex14 face a poor prognosis and only patients with METex14 are eligible for biomarker-driven therapy with TABRECTA.

Patients with METex14 in mNSCLC face a poor prognosis.

TABRECTA™ (capmatinib) 150 mg, 200 mg tablets is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Knowledge of METex14 status can inform an up-front treatment plan. Test for METex14 when a patient presents with mNSCLC (stage IV). METex14 is generally stable throughout the course of the disease.

  • It is imperative to use a test specifically designed to detect METex14 to identify patients who are eligible for treatment with TABRECTA™ (capmatinib) 150 mg, 200 mg tablets.
  • There have been specific algorithmic improvements applied to the pipeline in order to improve FoundationOne®CDx assay ability to detect METex14 skipping automatically.

The performance of FoundationOne®CDx to detect mutations leading to METex14 was demonstrated in a retrospective analysis of specimens from 78 patients enrolled in the GEOMETRY mono-1 trial.

  • GEOMETRY mono-1 was a multicenter, nonrandomized, open-label, multicohort study evaluating 97 adult patients with NSCLC with a mutation that leads to METex14 skipping. Patients received TABRECTA tablets 400 mg orally twice daily.
  • GEOMETRY mono-1 used an RNA-based reverse transcription-polymerase chain reaction (RT-PCR) assay to screen patients for METex14.
  • Out of 78 samples that were retested using FoundationOne®CDx, 73 were evaluable. FoundationOne®CDx demonstrated an estimated positive percentage agreement of 99% (72 of 73) with the RNA-based RT-PCR clinical trial assay, which confirmed METex14 skipping for TABRECTA.

Foundation Medicine generally expects to provide results in less than 2 weeks after the specimen is received. It is important to educate patients that the test results help inform up-front treatment plans.

For more information, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639.

For specimen shipment kits for FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639. 

For specimen handling instructions for FoundationOne®CDx, please visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639. 

Yes. Foundation Medicine's FoundationOne®CDx is an FDA-approved CGP test which uses next-generation sequencing for the detection of METex14.

For more information about the FoundationOne®CDx, visit FoundationOneCDx.com or contact Foundation Medicine at 1-888-988-3639. 

If you have questions about specimen types when ordering the FoundationOne®CDx, please contact Foundation Medicine at 1-888-988-3639 or visit FoundationOneCDx.com.

Indication

TABRECTA™ (capmatinib) 150 mg, 200 mg tablets is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information

Interstitial Lung Disease (ILD)/Pneumonitis. ILD/pneumonitis, which can be fatal, occurred in patients treated with TABRECTA. ILD/pneumonitis occurred in 4.5% of patients treated with TABRECTA in the GEOMETRY mono-1 study, with 1.8% of patients experiencing grade 3 ILD/pneumonitis and 1 patient experiencing death (0.3%). Eight patients (2.4%) discontinued TABRECTA due to ILD/pneumonitis.

Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, 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.

Hepatotoxicity. Hepatotoxicity occurred in patients treated with TABRECTA. Increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) occurred in 13% of patients treated with TABRECTA in GEOMETRY mono-1. Grade 3 or 4 increased ALT/AST occurred in 6% of patients. Three patients (0.9%) discontinued TABRECTA due to increased ALT/AST.

Monitor liver function tests (including ALT, AST, and total bilirubin) prior to the start of TABRECTA, 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 increased transaminases or bilirubin. Based on the severity of the adverse reaction, withhold, reduce dose, or permanently discontinue TABRECTA.

Risk of Photosensitivity. Based on findings from animal studies, there is a potential risk of photosensitivity reactions with TABRECTA. In GEOMETRY mono-1, it was recommended that patients use precautionary measures against ultraviolet exposure, such as use of sunscreen or protective clothing, during treatment with TABRECTA. Advise patients to limit direct ultraviolet exposure during treatment with TABRECTA.

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 of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with TABRECTA and for 1 week after the last dose.

Most Common Adverse Reactions. The most common adverse reactions (≥20%) were peripheral edema (52%), nausea (44%), fatigue (32%), vomiting (28%), dyspnea (24%), and decreased appetite (21%). The most common grade 3 adverse reactions (≥2%) were peripheral edema (9%), fatigue (8%), dyspnea (7%), nausea (2.7%), vomiting (2.4%), and noncardiac chest pain (2.1%). Grade 4 dyspnea was reported in 0.6% of patients.

Clinically Relevant Adverse Reactions. Clinically relevant adverse reactions observed in <10% of patients were pruritus (allergic and generalized), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.

Laboratory Abnormalities. Select laboratory abnormalities (≥20%) worsening from baseline in patients who received TABRECTA were decreased albumin (68%), increased creatinine (62%), decreased lymphocytes (44%), increased ALT (37%), increased alkaline phosphatase (32%), increased amylase (31%), increased gamma-glutamyltransferase (29%), increased lipase (26%), increased AST (25%), decreased hemoglobin (24%), decreased leukocytes (23%), decreased sodium (23%), decreased phosphate (23%), increased potassium (23%), and decreased glucose (21%).

Please see full Prescribing Information for TABRECTA.

FoundationOne® is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDx.com.

 

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