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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.

Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

Berg Partners With Department of Defense Research Center and Military Medical Foundation to Advance Prostate Cancer Research

Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological research approach, announced today an ambitious new partnership with the U.S. Department of Defense under a Cooperative Research and Development Agreement with the Uniformed Services University of the Health Sciences’ (USU) Center for Prostate Disease Research (CPDR) and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) to offer hope, and possibly one day a cure, for the 238,590 men diagnosed with prostate cancer each year.

“The CPDR has embarked on one of the most comprehensive prostate cancer research programs in the world and we are honored to be working with such a forward-thinking organization,” said Niven R. Narain, Co-Founder, President and CTO of Berg. “This collaboration is an ideal marriage of the CPDR’s extensive prostate cancer expertise and Berg’s unparalleled ability to drive a deeper level of biological understanding. Together, we have the potential to change the meaning of a prostate cancer diagnosis, and hopefully prognosis, while exemplifying how industry and government can work together to enact real change in public health.”

As part of this partnership, Berg and the CPDR will take a data-driven approach to drive molecular intelligence of prostate cancer by uncovering more accurate biomarkers and better therapies for patients. Berg will lend its expertise in computational biology and its proprietary Interrogative Biology™ Platform to analyze the CPDR’s extensive supply of prostate cancer data.

“Innovative collaborations, like this one with Berg, are the wave of the future in scientific discovery, and our goal is to illuminate actionable insights from the high volume of prostate cancer data we have generated to move science forward in a significant way,” said Army Colonel (ret) David G. McLeod, M.D., Director, and Albert Dobi, Ph.D., Associate Director at the CPDR.

Prostate cancer is the most commonly diagnosed non-cutaneous cancer in men and is the second most common cause of male death from cancer. In 2012, approximately 238,590 men in the U.S. were diagnosed with prostate cancer and an estimated 28,170 died from the disease. In addition, major population disparities in prostate cancer incidence and mortality need to be addressed through new diagnostic and prognostic marker discoveries.

Source: Berg Pharma

Abcodia and Cellmid Collaborate on the Studying of Midkine for Early Diagnosis of Colorectal Cancer

Abcodia Ltd, the UK biomarker validation company with a focus on early detection of cancer, today announced that it has entered into a collaboration agreement with Cellmid Ltd (ASX: CDY), for the testing of midkine (MK) in a collection of longitudinal serum samples using Cellmid’s MK-ELISA.

The initial objective of the collaboration is to validate midkine as a useful marker for the screening and early diagnosis of colorectal cancer. Serum samples will be provided by Abcodia and testing will be carried out by Cellmid.

The collaboration focuses on the assessment of midkine in pre-diagnosis serum samples. Abcodia has exclusive access to a unique biobank of 5,000,000 serum samples collected through the UK Collaborative Trial for Ovarian Cancer Screening.

The biobank was derived from 200,000 initially healthy volunteers. Since first recruitment, more than 27,000 individuals have been diagnosed with cancer. A subset of 50,000 individuals within the 200,000 cohort have provided samples annually, making this a unique longitudinal resource for testing midkine levels early, even before symptoms appear.

The collaboration agreement allows for the testing of multiple cancer indications, but initially targeting the early detection and screening of colorectal cancer. Colorectal cancer ranks third in incidence and second in cancer-related mortality in the United States.

Although the five year survival rate for stage 1 cancers is as high as 74%, for stage 4 cancers, when the cancer has metastasized, this reduces to just 6%. Early diagnosis of colorectal cancer, before the spread to the lymph nodes and distant sites, is vital to reduce death rates.

Midkine has been extensively validated as a biomarker in a range of other cancers. t has been shown to appear very early in some solid tumours with demonstrated utility in disease management and monitoring. Since 2012 midkine has been commercially used as one of the biomarkers in CxBladder®, a diagnostic test for the monitoring of bladder cancer patients.

Cellmid’s CEO, Maria Halasz, said: “We are excited to collaborate with the expert team at Abcodia to measure midkine levels in their extensive collection of pre-diagnosis serum samples. It is an exceptional opportunity for Cellmid to take part in the development of an important cancer diagnostic test.”

Abcodia’s CEO, Dr Julie Barnes, said: “I am delighted to be able to form this partnership with Cellmid. Midkine is an intriguing marker and I hope that we can reveal an interesting profile in the early pre-symptomatic phase of colorectal cancer. The uptake of current screening methods for colorectal cancer (colonoscopy and haemoccult testing) is low and a simple blood test could help significantly improve early diagnosis and therefore improve treatment outcomes.”

Source: Abcodia

U.S. FDA Approves Gilotrif (afatinib) as First-line Treatment for Lung Cancer Patients with EGFR Mutations

Boehringer Ingelheim announced last week that the U.S. Food and Drug Administration (FDA) has approved afatinib tablets under the U.S. brand name GILOTRIFTM for oral use, as a new first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Lung cancer is the biggest cancer killer in the world with incidence rates higher in men than in women, it accounts for 1.6 million new cancer cases annually. However, lung cancer isn’t just one disease; research has shown there are many different types requiring specific treatment approaches. One distinct subtype of lung cancer is defined by mutations in EGFR (a member of the ErbB Family of receptors). These are patients that in clinical trials have been shown to benefit most from afatinib treatment.

“We are delighted to announce the first approval of afatinib, offering a new personalised treatment approach for patients with EGFR mutation positive NSCLC,” said Prof Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. “It marks the first of what we hope will be many products to emerge from our oncology research and development programme, and underscores our continued commitment to translating innovative science into new treatment options for patients.”

In the U.S., afatinib received orphan drug status and was assessed under the FDA’s priority review programme, which provides an expedited review for drugs that may provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. Boehringer Ingelheim strives to make afatinib available to patients around the world. Afatinib has been submitted to the EMA and regulatory authorities in Asia and other countries for treatment of EGFR mutation positive locally advanced and metastatic NSCLC.

The approval of afatinib in the U.S. is based on data from the pivotal LUX-Lung 3 trial, comparing afatinib to chemotherapy with pemetrexed/cisplatin. Data from LUX-Lung 3 has shown that patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing again (median progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those treated with pemetrexed/cisplatin. In addition, NSCLC patients with tumours harbouring the two most common EGFR mutations (Del19 or L858R) taking afatinib lived for well over a year without tumour progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.

In addition, patients taking afatinib also experienced an improvement in lung cancer symptoms and a better quality of life compared to those receiving standard chemotherapy treatment.

The most common grade 3 drug-related adverse events observed in the afatinib treatment arm were diarrhoea (14%), rash (16%), and inflammation of the nail bed (paronychia) (11%). The most common drug-related grade 3 adverse events observed in the chemotherapy arm (pemetrexed/cisplatin) were neutropenia (15%), fatigue (13%), and leucopenia (8%). There was a low discontinuation rate associated with treatment-related adverse events in the trial (8% discontinuation rate for afatinib; 12% for chemotherapy). One percent of patients in the afatinib arm discontinued due to drug-related diarrhoea.

Study: Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations

Source: Boehringer Ingelheim