publication date: Oct. 31, 2014

Lymphoseek Label Expanded To Include Mapping Solid Tumors


FDA approved the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors, and adding sentinel lymph node detection for breast cancer and melanoma to the approved indications.

The FDA also allowed expanded utilization of Lymphoseek with or without scintigraphic imaging, known as lymphoscintigraphy, to enable pre-operative imaging and mapping of lymph nodes to facilitate node localization during surgical procedures. Lymphoseek is developed by Navidea Biopharmaceuticals Inc.

Lymphoseek is the first and only FDA-approved radiopharmaceutical agent for sentinel lymph node detection, is the only FDA-approved agent for lymphatic mapping of solid tumors, and will be immediately available using existing reimbursement codes for this expanded population of cancer patients.

The expanded approval is supported by data from Navidea’s combined analysis of Lymphoseek’s prospective phase III data in melanoma, breast cancer, and certain head and neck cancers from more than 500 subjects. Findings indicated that Lymphoseek accurately identified lymph nodes for assessment in the trial subjects, and is likely to be predictive of overall node pathology status.


THE CENTERS FOR MEDICARE AND MEDICAID SERVICES published a draft local coverage determination for the Decipher Prostate Cancer Classifier developed by GenomeDx Biosciences. The determination describes coverage and payment policy for use of the Decipher test in men who have undergone radical prostatectomy.

Under Medicare policies, a 45-day comment period will commence on Nov. 10. After comments are received and revisions, if any, are made to the draft LCD, the final LCD will be posted within 45 calendar days.

Palmetto GBA, a national contractor that administers Medicare benefits, has issued the draft LCD through the MolDX Program for Decipher. MolDX, developed in 2011, facilitates the clinical review, coverage and payment policies for molecular diagnostic tests. The MolDX Program is a contractor to Noridian, a national contractor that administers Medicare benefits for Jurisdiction E, where GenomeDx is located.

Decipher is a unique genomic test intended for men who have had prostate surgery and are considered by guidelines to be at high-risk for their cancer returning. These are men who have specific risk factors for cancer recurrence, including positive surgical margins, stage T3 disease (seminal vesicle invasion, extraprostatic extension, bladder neck invasion) or rising PSA after initial PSA nadir.


THE NATIONAL COMPREHENSIVE CANCER NETWORK approved the VeriStrat predictive proteomics test for inclusion in its Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancer. The test is developed by Biodesix Inc.

The updated guidelines recommend clinicians’ use of VeriStrat, a blood-based protein profiling test, to help determine whether patients entering the second line of treatment for NSCLC should be considered as candidates to receive the targeted drug erlotinib (Tarceva).

The guidelines state: “Recommended proteomic testing for patients with NSCLC and wild-type EGFR or with unknown EGFR status. A patient with a ‘poor’ classification should not be offered erlotinib in the second-line setting.” Erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor therapy, is commonly used in NSCLC patients who harbor an activating EGFR mutation.

An independent phase III clinical trial (PROSE) for VeriStrat confirmed the test’s results are prognostic and specifically predictive of differential overall survival benefit for erlotinib versus chemotherapy in the second-line setting. Successful trial results were recently published in The Lancet Oncology.


MYRIAD GENETICS Inc. established a Tumor BRACAnalysis CDx laboratory in Munich.

The test is a companion diagnostic used to identify patients with BRAC mutations who may benefit from treatment with PARP inhibitors, such as olaparib, a novel PARP inhibitor being developed by AstraZeneca.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recently recommended marketing authorization for olaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.


UNIVERSITY HOSPITALS Case Medical Center and UH Seidman Cancer Center selected GO Clinical Workbench developed by GenomOncology for workflow management of next generation sequencing data.

The platform allows molecular pathology laboratories to produce an actionable clinical report using the molecular profile of an individual patient’s tumor.


QIAGEN N.V. and Astellas Pharma Inc. will collaborate to develop and commercialize companion diagnostics paired with Astellas drugs for use in cancer and other diseases.

Two initial projects in the collaboration focus on oncology and aim to pair Qiagen diagnostics with Astellas compounds in early-stage clinical trials: ASP5878, a fibroblast growth factor receptor inhibitor, and ASP8273, an EGFR inhibitor. Financial terms were not disclosed.

The scope of the agreement is not restricted to certain sample types, platforms, indications or biomarkers, giving Astellas access to Qiagen’s assays based on PCR, next generation sequencing and multi-modal testing technologies using liquid and tissue biopsies.

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