FDA-Approved Content Report Section 1
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SAMPLE REPORT New FDA-Approved Broad Companion Diagnostic for Solid Tumors FDA-Approved Content Report Section 1 1 FDA-Approved Therapies PATIENT TUMOR TYPE TRF# List of FDA-approved Jane Sample Lung adenocarcinoma TRFXXXXXX companion diagnostics to PATIENT PHYSICIAN SPECIMEN identify patients who may DISEASE Lung adenocarcinoma ORDERING PHYSICIAN Not Given SPECIMEN SITE Not Given NAME Not Given MEDICAL FACILITY Not Given SPECIMEN ID Not Given benefi t from associated DATE OF BIRTH Not Given ADDITIONAL RECIPIENT Not Given SPECIMEN TYPE Not Given SEX Female MEDICAL FACILITY ID Not Given DATE OF COLLECTION Not Given therapies MEDICAL RECORD # Not Given PATHOLOGIST Not Given SPECIMEN RECEIVED Not Given CDx Associated Findings 1 GENOMIC FINDINGS DETECTED FDA-APPROVED THERAPEUTIC OPTIONS 2 All Other Biomarkers EGFR L858R Gilotrif® (Afatinib) All other biomarkers, Iressa® (Gefitinib) including tumor mutational Tarceva® (Erlotinib) burden (TMB) and 2 microsatellite instability (MSI), without companion OTHER ALTERATIONS & BIOMARKERS IDENTIFIED Results reported in this section are not prescriptive or conclusive for labeled use of any specific therapeutic product. See diagnostic claims professional services section for additional information. Microsatellite Status MS-Stable PTCH1 T416S Tumor Mutation Burden 11 Muts/Mb RBM10 Q494* CDKN2A/B loss TP53 R267P EGFR amplification § Refer to appendix for limitation statements related to detection of any copy number alterations, gene rearrangements, MSI or TMB result in this section. Please refer to appendix for Explanation of Clinical Significance Classification and for variants of unknown significance (VUS). FoundationOne CDx™ (F1CDx) is a next generation TABLE 1 sequencing based in vitro diagnostic device for detection of INDICATIONS BIOMARKER THERAPY substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene EGFR exon 19 deletions and EGFR exon 21 L858R alterations Gilotrif® (Afatinib), Iressa® (Gefitinib), or Tarceva® (Erlotinib) rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden Non-small cell EGFR exon 20 T790M alterations Tagrisso® (Osimertinib) (TMB) using DNA isolated from formalin-fixed paraffin lung cancer (NSCLC) ALK rearrangements Alecensa® (Alectinib), Xalkori® (Crizotinib), or Zykadia® (Ceritinib) embedded (FFPE) tumor tissue specimens. The test is intended as a companion diagnostic to identify patients who BRAF V600E Tafinlar® (Dabrafenib) in combination with Mekinist® (Trametinib) may benefit from treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic BRAF V600E Tafinlar® (Dabrafenib) or Zelboraf® (Vemurafenib) Melanoma product labeling. Additionally, F1CDx is intended to provide BRAF V600E or V600K Mekinist® (Trametinib) or Cotellic® (Cobimetinib) in combination with Zelboraf® (Vemurafenib) tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in Breast cancer ERBB2 (HER2) amplification Herceptin® (Trastuzumab), Kadcyla® (Ado-trastuzumab emtansine), or Perjeta® (Pertuzumab) oncology for patients with solid malignant neoplasms. The F1CDx assay is a single-site assay performed at Foundation KRAS wild-type (absence of mutations in codons 12 and 13) Erbitux® (Cetuximab) Medicine, Inc. Colorectal cancer KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) Vectibix® (Panitumumab) Ovarian cancer BRCA1/2 alterations Rubraca® (Rucaparib) ABOUT THE TEST FoundationOne CDx™ is the first FDA-approved broad companion diagnostic for solid tumors. Electronically Signed by Julia A. Elvin, M.D., Ph.D. • Jeffrey S. Ross, M.D., Medical Director • 30 November 2017 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Foundation Medicine, Inc. • 1-888-988-3639 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 FDA-APPROVED CONTENT — PAGE 1 of 1 Professional Services Report Section 2 1 Pertinent Negatives PATIENT TUMOR TYPE TRF# Jane Sample Lung adenocarcinoma TRFXXXXXX Identifi es important negative results that can be used for patient management Interpretive content on this page and subsequent Biomarker Findings pages is provided as a professional service, and is Microsatellite status - MS-Stable not reviewed or approved by the FDA. Tumor Mutation Burden - TMB-Intermediate (11 Muts/Mb) PATIENT DISEASE Lung adenocarcinoma Genomic Findings NAME Not Given For a complete list of the genes assayed, please refer to the appendix. 2 Therapies with Clinical Benefi t DATE OF BIRTH Not Given EGFR amplification, L858R Interpretive content that can be SEX Female PTCH1 T416S MEDICAL RECORD # Not Given CDKN2A/B loss used for patient management PHYSICIAN RBM10 Q494* ORDERING PHYSICIAN Not Given TP53 R267P according to professional MEDICAL FACILITY Not Given ADDITIONAL RECIPIENT Not Given 6 Disease relevant genes with no reportable alterations : KRAS, ALK, guidelines in oncology MEDICAL FACILITY ID Not Given BRAF, MET, RET, ERBB2, ROS1 PATHOLOGIST Not Given 1 SPECIMEN 7 Therapies with Clinical Benefit in patient’s tumor type 18 Clinical Trials SPECIMEN SITE Not Given 7 Therapies with Clinical Benefit in other tumor type SPECIMEN ID Not Given SPECIMEN TYPE Not Given DATE OF COLLECTION Not Given 3 Clinical Trials SPECIMEN RECEIVED Not Given Identifi es trials based on 2 THERAPIES WITH CLINICAL BENEFIT THERAPIES WITH CLINICAL BENEFIT patients’ unique genomic BIOMARKER FINDINGS (IN PATIENT’S TUMOR TYPE) (IN OTHER TUMOR TYPE) profi le with page number Tumor Mutation Burden Atezolizumab Avelumab TMB-Intermediate (11 Muts/Mb) for quick reference Nivolumab Durvalumab 3 9 Trials see p. 14 Pembrolizumab Microsatellite status MS-Stable No therapies or clinical trials. see Biomarker Findings section THERAPIES WITH CLINICAL BENEFIT 2 THERAPIES WITH CLINICAL BENEFIT GENOMIC FINDINGS (IN PATIENT’S TUMOR TYPE) (IN OTHER TUMOR TYPE) EGFR amplification, L858R Afatinib Cetuximab Erlotinib Lapatinib Gefitinib Panitumumab 3 4 Trials see p. 15 Osimertinib PTCH1 T416S none Sonidegib 5 Trials see p. 17 Vismodegib e content provided as a professional service by Foundation Medicine, Inc., has not been reviewed or approved by the FDA. Electronically Signed by Julia A. Elvin, M.D., Ph.D. • Jeffrey S. Ross, M.D., Medical Director • 30 November 2017 Sample Preparation: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 Foundation Medicine, Inc. • 1-888-988-3639 Sample Analysis: 150 Second St., 1st Floor, Cambridge, MA 02141 • CLIA: 22D2027531 PROFESSIONAL SERVICES — PAGE 1 of 17 TO LEARN MORE: TO ORDER: Visit www.foundationmedicine.com/f1cdx Available to order in early 2018 FoundationOne CDx™ is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fi xed, para n-embedded (FFPE) tumor tissue specimens. For the complete intended use statement, including companion diagnostic indications, please see the FoundationOne CDx Technical Information, www.foundationmedicine.com/f1cdx. © 2017 Foundation Medicine, Inc. | FoundationOne® is a registered trademark of Foundation Medicine, Inc. FoundationOne CDx™ is a trademark of Foundation Medicine, Inc. | www.foundationmedicine.com | Tel. 888.988.3639 | Fax 617.418.2290 | MKT-0144-01.