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Roche Receives FDA Approval for VENTANA ALK (D5F3) CDx Assay to Identify Lung Cancer Patients Eligible for Treatment with Roche’s ALECENSA (alectinib)

Roche recently announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA® (alectinib). The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.

Enzymatics Launches Archer Targeted Sequencing Technology to Dramatically Enhance Gene Mutation Identification and Discovery

Enzymatics, Inc., a leading producer of molecular biology reagents, kits, assays and software, recently unveiled Archer™ Targeted Sequencing technology, which dramatically enhances gene mutation identification and discovery with high sensitivity and reduced costs. The technology was announced during the Advances in Genome Biology & Technology (AGBT) conference, which is recognized throughout the sequencing community as a cornerstone for the discussion of genomics research.

Ventana Receives Approval from China’s FDA for First Fully Automated IHC Companion Diagnostic Identifying ALK Protein Expression in Lung Cancer Patients

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the approval of the VENTANA ALK immunohistochemistry (IHC) assay by the Chinese Food and Drug Administration (CFDA) as a companion diagnostic to aid in the identification of patients for Pfizer’s CFDA-approved oncology product XALKORI® (crizotinib). The VENTANA ALK (D5F3) Rabbit Monoclonal Primary Antibody assay is designed to identify ALK-positive patients in non-small cell lung cancer (NSCLC) patients1. The approval is based on a retrospective study that included 1100 Chinese subjects across three national hospitals where the VENTANA assay demonstrated 99.23 percent concordance with Abbott’s Vysis ALK Break Apart FISH Probe Kit.

Personalizing Lung Cancer Care Through Biomarker Testing

The concept of personalized medicine – matching a patient’s unique genetic profile with an appropriate and more individualized treatment plan – is transforming the care of patients with cancer.

Over the last decade, the scientific community has gained a greater understanding of genetic mutations, or abnormalities, associated with the development and progression of cancer; these mutations are also known as biomarkers. The presence or absence of a biomarker can help physicians determine the most appropriate treatment approach for each individual patient based on their specific type of cancer.

In some cancers, like breast cancer, testing for biomarkers is already an established best practice.

However, for other cancers, the regular use of biomarker testing is still gaining momentum; non-small cell lung cancer (NSCLC) is one example.

NSCLC is the most common type of lung cancer – in fact, about 85 percent of patients with lung cancer are diagnosed as having NSCLC. Today, there have been multiple biomarkers identified and believed or known to play a role in the development and progression of this disease. One of these biomarkers is a mutation in a protein known as epidermal growth factor receptor (EGFR); it is one of the most common biomarkers identified in NSCLC patients. Another biomarker being closely studied in NSCLC is anaplastic lymphoma kinase (ALK) rearrangements. Approximately 10 to 15 percent of patients with advanced non-small cell lung cancers have EGFR mutations, while another two to seven percent have ALK rearrangements.

There have been significant advancements in the research of NSCLC over the past 10 years including increased knowledge of biomarkers, which can inform treatment decisions.

Traditional surgery, radiation and chemotherapy, which can remove or kill some normal cells along with cancer cells, were once the only options; however, targeted therapies are now an option for some patients who have a biomarker. Targeted therapies generally work by influencing the processes that control growth, division, and spread of cancer cells, as well as the signals that cause cancer cells to die naturally (apoptosis), the way normal cells do when they are damaged or old.

“The discovery of genetic mutations and the process of testing for them – known as biomarker testing – is changing the diagnosis and treatment landscape for patients with cancer,” said Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “It allows us to determine if a patient’s cancer is associated with a genetic mutation, leading to a more detailed diagnosis and giving us the tools we need to map out an individualized treatment approach for each patient.”

Ideally, biomarker testing happens immediately after a patient is diagnosed with a disease like lung cancer to help ensure that he or she can start on the most appropriate treatment as early as possible.

A team – that may include pulmonologists, pathologists, oncologists and other health professionals – typically works together in the diagnosis and treatment of patients with lung cancer, including biomarker testing. There are multiple steps involved in biomarker testing for patients with advanced NSCLC, including:

  • Taking a sample of lung tissue from a patient
  • Analyzing/confirming type of lung cancer
  • Testing the tissue sample for biomarkers
  • Determining an individualized treatment approach

What can you do? You can increase the awareness of biomarker testing. If you or a loved one is diagnosed with lung cancer, be empowered by asking about biomarker testing. You can learn more about the biomarker testing process via an easy-to-understand brochure titled, “Individualizing Your Lung Cancer Care: Informing Decisions Through Biomarker Testing,” which can be found on http://onebreath.org and was developed by Boehringer Ingelheim in collaboration with the American College of Chest Physicians (ACCP) and EmergingMed.

Healthcare professionals involved in the care of patients with lung cancer can find out more through Boehringer Ingelheim’s Let’s Test initiative (www.LetsTestNow.com) to learn more about the importance of automatically testing for biomarkers in advanced NSCLC and the importance of a multidisciplinary, collaborative approach to testing.

Source: Idaho State Journal

MolecularMD Corp. Obtains License to Commercialize Predictive Diagnostic Based on Actionable Biomarker, DDR2, for Uses in Lung Cancer and Targeted Kinase Therapy

MolecularMD Corp. recently announced that it has entered into a license agreement granting the company exclusive patent rights to cancer diagnosis technology. Specifically, MolecularMD has obtained rights to commercialize patent-pending intellectual property pertaining to DDR2 mutations for diagnostic, prognostic and predictive uses for humans in the area of lung cancer. Such patent rights are jointly-owned by The Broad Institute and Dana-Farber Cancer Institute. The inventors named on the patent are Drs. Matthew Meyerson, Peter Hammerman, and Alexis Ramos.

About DDR2 Mutations in Lung Cancer

Research into understanding the genetic basis of cancer has led to identification of novel biomarkers that have been successfully exploited with targeted therapies. In non-small cell lung cancer (NSCLC), several such targets have been discovered for adenocarcinoma including EGFR, ALK, and MET. Unfortunately, these therapeutic targets are not relevant for squamous cell carcinoma (SCC), which is the second most frequent histological subtype in NSCLC. Recent discoveries identified mutations in the discoidin domain receptor 2 (DDR2) of SCC patient tumors that are oncogenic and also responsive to existing drugs targeting kinase inhibition. DDR2 is a membrane receptor tyrosine kinase involved in cell adhesion, proliferation and migration. In xenograft models, DDR2-mutant tumors regressed under treatment with the tyrosine kinase inhibitor, dasatinib. Remarkably, an SCC patient with no detectable EGFR mutation had a long-term response to the combination of erlotinib plus dasatinib. This patient was found to harbor a DDR2 mutation further suggesting that DDR2 mutations may be clinically relevant. Given the availability of a variety of therapies targeting tyrosine kinases, these findings provide a rationale for designing clinical trials for patients with SCC using existing FDA-approved drugs such as dasatinib, imatinib, nilotinib and ponatinib as well as novel, selective tyrosine kinase inhibitors for DDR2.

MolecularMD is developing DDR2 diagnostic assays, including next-generation sequencing tests, for clinical trials exploring efficacy of targeted therapies and DDR2 clinical utility. MolecularMD provides comprehensive clinical trial support through its CLIA-certified and CAP-accredited Clinical Reference Laboratory. In addition, MolecularMD provides IVD development and manufacturing capability to support companion diagnostic device commercialization. MolecularMD will also support commercialization of DDR2 technology through sublicensing to clinical reference laboratories and diagnostic assay developers and manufacturers.

According to Dr. Greg Cox, MolecularMD’s Director of Licensing, “DDR2 is potentially the first actionable biomarker available for SCC patients, whose treatment options are currently limited to chemotherapy. It’s exciting that these patients may benefit from existing FDA-approved targeted therapies, and we are eager to support clinical trials examining these novel treatment possibilities and enable widespread access to DDR2 diagnostics.”