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Caris Life Sciences Launches Significant Enhancements to Industry-leading Cancer Tumor Profiling Service

Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, recently launched significant enhancements to its Molecular Intelligence™ tumor profiling service. These enhancements include significant updates to MI Portal™, the company’s online physician resource, a streamlined molecular profiling panel structure and the addition of two biomarkers.

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.

FDA Advisory Committee Recommends Accelerated Approval of Genentech’s Perjeta for Neoadjuvant Use in 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’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 13 to 0, with one abstention, in favor of recommending accelerated approval of a Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer. The FDA will make a decision on whether or not to approve Perjeta for this use by October 31, 2013. If approved, the Perjeta regimen will be the first neoadjuvant breast cancer treatment approved in the United States and the first treatment approved based on pathological complete response (pCR) data, meaning there is no tumor tissue detectable at the time of surgery.

Perjeta is already approved in a number of countries including the United States for people with HER2-positive metastatic breast cancer (an advanced form of the disease in which the cancer has spread to other parts of the body).

The Perjeta application for neoadjuvant use follows a proposed new FDA pathway designed to more quickly bring promising medicines to people with earlier stages of breast cancer, where treatment may have a greater impact.

“More than 6,000 people in the United States die of HER2-positive breast cancer each year,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “The ODAC’s recommendation is a step toward bringing Perjeta to people with HER2-positive early stage breast cancer, where treatment can potentially prevent the disease from returning and spreading.”

Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working and may also reduce a tumor’s size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early stage breast cancer.

The ODAC recommendation was based on a review of results from NEOSPHERE and TRYPHAENA, two Phase II studies of Perjeta in high-risk, HER2-positive early stage breast cancer, as well as on longer-term safety data from the Phase III CLEOPATRA study of Perjeta in HER2-positive metastatic breast cancer.

The ongoing Phase III APHINITY study will further evaluate Perjeta in the adjuvant setting (after surgery) and compares Perjeta, Herceptin® (trastuzumab) and chemotherapy with Herceptin and chemotherapy in people with HER2-positive early stage breast cancer. The study has completed enrollment with approximately 4,800 people, and the primary endpoint is invasive disease-free survival (IDFS). Genentech has proposed this study as a confirmatory study to the FDA. Data are expected in 2016.

Source: Genentech

Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.