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Researchers Discover Biomarker, Potential Targeted Therapy for Pancreatic Cancer

University of Cincinnati (UC) researchers have discovered a biomarker, known as phosphatidylserine (PS), for pancreatic cancer that could be effectively targeted, creating a potential therapy for a condition that has a small survival rate.

Genomic Health Announces Presentation of Oncotype DX Studies Reinforcing Value of Tests in Guiding Treatment for Multiple Cancers

Genomic Health, Inc. (Nasdaq: GHDX) recently announced results from four studies highlighting the value of its Oncotype DX® tests for optimizing treatment for patients with breast and colon cancer. Three new decision impact studies – including the company’s first international decision impact study in colon cancer and additional evidence for the Oncotype DX breast cancer test’s significant impact on breast cancer treatment decisions in the United Kingdom (UK) – were among data presented at the European Cancer Congress 2013 in Amsterdam. The results were presented on the heels of the recent National Institute for Health and Care Excellence (NICE) guidance announcement that recommended the use of Oncotype DX “as an option to help clinicians decide whether to prescribe chemotherapy in people with early breast cancer.”

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.

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

Analysis Published In New England Journal of Medicine Highlights Discovery of New Predictive Biomarkers for Vectibix (Panitumumab)

Amgen (NASDAQ: AMGN) recently announced the publication of a biomarker analysis of Vectibix® (panitumumab) in combination with FOLFOX, a type of oxaliplatin-based chemotherapy, for the first-line treatment of patients with metastatic colorectal cancer (mCRC). Published in the New England Journal of Medicine, the analysis found that RAS mutations, beyond the known KRAS exon 2 mutations, predict lack of response to Vectibix in combination with FOLFOX. RAS mutations are mutations occurring in exons 2, 3 and 4 of KRAS and NRAS.