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FDA Grants Genentech’s Perjeta Accelerated Approval for Use Before Surgery in People With HER2-Positive Early Stage Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), recently announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin® (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.

New Study Shows Circulating Tumor Cell Enumeration – as Part of Composite Biomarker Panel – May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer

Janssen Diagnostics, LLC recently announced results from a study presented at the European Cancer Congress in Amsterdam, Netherlands, that demonstrated circulating tumor cell (CTC) enumeration using CELLSEARCH®, along with lactate dehydrogenase (LDH) as part of a composite biomarker panel, was an efficacy-response surrogate for survival in managing patients with metastatic castration-resistant prostate cancer (mCRPC). The results show mCRPC patients with greater than or equal to five CTCs and an abnormal LDH level at 12 weeks of treatment have a poorer prognosis than those with lower CTC counts and normal LDH values, with a one- and two-year survival probability of 25 percent and 2 percent compared to 82 percent and 46 percent, respectively. Findings suggest therapeutic alternatives should be considered for patients in the high-risk category at 12 weeks.

West Clinic Researchers Present Findings at 2013 American Society for Clinical Oncology (ASCO) Meeting

The West Clinic, the Mid-South’s premier cancer center and world-class center of excellence in medical oncology, hematology, oncologic imaging, clinical research and other advanced medical care, recently announced five of its physician-researchers will participate in ten presentations at the 49th Annual American Society of Clinical Oncology (ASCO) Meeting to be held May 31-June 4, 2013 in Chicago, IL at the McCormick Palace. Over 30,000 members of the oncology community from across the nation and around the world are expected to attend the five-day international scientific and educational oncology conference. This year’s theme is “Building Bridges to Conquer Cancer.”

The West Clinic’s findings, which focus on leading-edge treatments for non-small cell lung cancer, colorectal cancer, lymphoma, and breast cancer, were selected by a highly competitive peer-review process.

“The West Clinic continues to further its research mission with a strong showing at ASCO, the world’s premier oncology meeting,” according to Lee S. Schwartzberg, MD, FACP, Medical and Research Director, The West Clinic; President, ACORN Research, LLC; and Chief, Division of Hematology/Oncology and Professor of Medicine, University of Tennessee Health Science Center. “Over 5000 abstracts from around the world were submitted this year. Our invitation to present four out of five West Clinic/ACORN abstracts reflects our reputation for being a major oncology research center. We are also pleased that our Chief Fellow, Dr. Jessica Snider, is first author on an important neo-adjuvant breast cancer trial that she will present.”

Landmark research has been a heritage of The West Clinic and its continued commitment to a robust program is strong with participation in approximately 40 open studies, 12 of which are Phase I. West Clinic physicians conduct a broad spectrum of clinical research trials ranging from Phase I to Phase IV studies in collaboration with major pharmaceutical companies, the National Cancer Institute, cooperative groups, and its own investigator initiated trials funded by grants. West Clinic has one of the most advanced research programs of its kind in the country and played a major role in the development of new drugs for breast cancer, colon cancer, lung cancer, prostate cancer, lymphoma, and many other diseases.

“This year’s theme Building Bridges to Conquer Cancer parallels our vision and unique collaboration with the University of Tennessee Health Science Center, Methodist Healthcare, and researchers across the country through ACORN Research, further positioning West Clinic as an innovative leader, exploring new cancer-fighting treatments, and saving more lives,” stated Dr. Schwartzberg.

The following West Clinic physicians contributed to ASCO presentations.

GENERAL POSTER PRESENTATIONS

  1. Dr. Lee Schwartzberg: Serum and tumor biomarkers to predict outcome in the eLung trial, a multicenter, randomized phase IIb study of standard platinum doublets (PD) plus cetuximab (CET) as first-line treatment of advanced non-small cell lung cancer (NSCLC). http://abstracts2.asco.org/AbstView_132_110479.html
  2. Dr. Lee Schwartzberg; Dr. Obiageli Ogbata: Real-world symptom burden and early treatment discontinuation in first-line metastatic breast cancer (MBC). http://abstracts2.asco.org/AbstView_132_110594.html
  3. Dr. Lee Schwartzberg: From Bayesian modeling to genomic mapping: Biologic validity of predictive single nucleotide polymorphism networks for chemotherapy-related side effects. http://abstracts2.asco.org/AbstView_132_114956.html
  4. Dr. Lee Schwartzberg: Phase I/II study of neoadjuvant carboplatin, eribulin mesylate, and trastuzumab (ECH) for operable HER2 positive (HER2+) breast cancer. http://abstracts2.asco.org/AbstView_132_110308.html
  5. Dr. Lee Schwartzberg: Analysis of KRAS/NRAS mutations in PEAK: A randomized phase II study of FOLFOX6 plus panitumumab (pmab) or bevacizumab (bev) as first-line treatment (tx) for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC). http://abstracts2.asco.org/AbstView_132_116726.html
  6. Dr. Lee Schwartzberg: Initial results from the 21-gene breast cancer assay registry: A prospective observational study in patients (pts) with ER+, early-stage invasive breast cancer (EBC). http://abstracts2.asco.org/AbstView_132_113096.html
  7. Dr. Lee Schwartzberg: Phase II study of lapatinib in combination with vinorelbine, as first- or second-line therapy in women with HER2-overexpressing metastatic breast cancer. http://abstracts2.asco.org/AbstView_132_115057.html
  8. Dr. Jessica Snider: Pathologic complete response (pCR) with weekly nanoparticle albumin bound (nab-P) plus carboplatin (C) followed by doxorubicin plus cyclophosphamide (AC) with concurrent bevacizumab (B) for triple-negative breast cancer (TNBC). http://abstracts2.asco.org/AbstView_132_117576.html
  9. Dr. Brad Somer: Randomized phase II study with window-design to evaluate anti-tumor activity of the survivin antisense oligonucleotide (ASO) ly2181308 in combination with docetaxel for first-line treatment of castrate-resistant prostate cancer (CRPC). http://abstracts2.asco.org/AbstView_132_108714.html
  10. Dr. Daruka Mahadevan: Genetic and cytokine profiles associated with symptomatic stage of CLL. http://abstracts2.asco.org/AbstView_132_113916.html

PUBLICATIONS ONLY

  1. Dr. Lee Schwartzberg: A phase IIb trial of coix seed injection for advanced pancreatic cancer. http://abstracts2.asco.org/AbstView_132_115489.html
  2. Dr. Daruka Mahadevan: Phase Ib study of safety, tolerability, and efficacy of R1507 a monoclonal antibody to IGF-1R in combination with multiple standard chemotherapy regimens in patients with advanced solid malignancies. http://abstracts2.asco.org/AbstView_132_110601.html

Source: PR Newswire

Saladax Biomedical, Inc. Extends Availability of its MyCare Portfolio in Europe

Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, recently announced the company has achieved CE mark registration for its MyPaclitaxel and MyDocetaxel therapeutic dose management (TDM) MyCare assays, enabling commercialization in the European Union (EU).

Vanderbilt-led Study Identifies Genes Linked to Resistance to Breast Cancer Chemotherapy

A study led by Vanderbilt-Ingram Cancer Center (VICC) investigators has identified a gene expression pattern that may explain why chemotherapy prior to surgery isn’t effective against some tumors and suggests new therapy options for patients with specific subtypes of breast cancer.