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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.

Multiplicom Launches Three New Mutation Detection Kits to Enable the Implementation of Personalized Cancer Treatment

Multiplicom NV, a specialist in the development, production and commercialization of innovative molecular genetic tests based on massively parallel sequencing (MPS), recently announced that it is launching three new somatic mutation detection kits which will enable users to implement personalized cancer treatment at an unprecedented level.

Evidence-Guided Molecular Profiling Offers New Hope for Oncologists Managing Difficult-to-Treat Cancers

Caris Life Sciences recently announced data from two studies presented at the 2013 European Cancer Congress (ECC 2013), which demonstrate the potential of evidence-guided molecular profiling to improve the treatment of patients with hard-to-treat cancers, including cancers of unknown primary (CUP) origins as well as rare tumors and cancers that have been refractory to treatment.

Test Could Identify Which Prostate Cancers Require Treatment

The level of expression of three genes associated with aging can be used to predict whether seemingly low-risk prostate cancer will remain slow-growing, according to researchers at the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center. Use of this three-gene biomarker, in conjunction with existing cancer-staging tests, could help physicians better determine which men with early prostate cancer can be safely followed with “active surveillance” and spared the risks of prostate removal or other invasive treatment. The findings were published recently in the online edition of Science Translational Medicine.

Ganymed Pharmaceuticals Announces CE Marking for Test to Assess Claudin-18.2 Expression in Solid Tumors

Ganymed Pharmaceuticals announced today that it has fully developed and obtained CE marking for its in vitro diagnostic (IVD) test CLAUDETECTTM18.2 which allows to assess the expression levels of Claudin-18.2 (CLDN18.2) in solid tumors. CLAUDETECTTM18.2, which was developed in collaboration with Theracode GmbH, is now compliant with the requirements of European Community Directive 98/79/EC on in vitro diagnostic medical devices.