Oncology Business Management

The Third Annual IPCC: "Translating Advances into Clinical Practice," is to be held in New York City on Saturday, March 27, 2010. Recent developments in the prevention, diagnosis, and treatment of prostate cancer most relevant to community-based physicians will form the core areas of discussion.

Oncology & Biotech News (OBTN) starts its fourth year of publication with a new look and an even stronger focus on bringing you the latest developments in clinical trial research, practice guidelines, and regulatory information.

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is one of only 40 cancer centers in the country designated by the National Cancer Institute as a Comprehensive Center. The physician researchers at the institution have been characterizing the acquired genome defects in cancers for the better part of the past few decades.

Executives at Radient Pharmaceuticals Corporation may one day look back on 2009 as the year when the coming-out party for the two-decades-old firm located in Tustin, California, began.

If there is such a thing as a business trifecta, Seattle Genetics is nearly there. The Washington state biotechnology company is focused on the development and commercialization of monoclonal antibody–based therapies for the treatment of cancer and autoimmune disease. And with a potent pipeline of potential products and numerous technology and marketing collaborations in place, the opportunities for growth are in the air.

When companies talk about "narrowing the gap," they typically mean closing the distance that separates them from their leading competitor. At Ariad Pharmaceuticals, however, that expression has taken on a new meaning: narrowing the distance from development to market for its two most promising compounds.

At the 2010 Gastrointestinal Cancers Symposium, researchers from two studies reported that the Oncotype DX colon cancer test, combined with extended lymph node assessment,helped identify patients at high risk of recurrence for stage II colorectal cancer after surgery.

A study presented at the 51st American Society of Hematology Meeting and Expedition reported that 5 days of palonosetron (Aloxi) was significantly more effective than ondansetron at preventing delayed chemotherapy-induced nausea and vomiting (CINV) in patients with acute myelogenous leukemia (AML).

Sunitinib malate (Sutent)doubled progression-free survival (PFS) in a phase III trial involving patients with pancreatic neuroendocrine tumors (NETs). Data were presented at the 2010 Gastrointestinal Cancers Symposium in January.

At the 2010 Gastrointestinal Cancers Symposium, new data from the CRYSTAL trial identified BRAF gene mutations as a poor prognostic indicator in metastatic colorectal cancer (mCRC) but not predictive of response to therapy.

August has traditionally been a sleepy month for government regulatory agencies, but this year, Washington's usual summer torpor was interrupted by a rush of new initiatives, as more than three-quarters of a trillion dollars from the American Recovery and Reinvestment Act surged into a mind- boggling range of projects.

The American Recovery and Reinvestment Act (ARRA) of 2009 designated $87 billion for state Medicaid programs, enacting major increases in federal matching rates. Despite the boost from ARRA, state budgets have been groaning under the weight of the economic downturn, with 29 of them planning to make Medicaid cuts in 2010.

Advances in diagnostic imaging have led to general improvement in treating patients for various maladies. Recently, advances in breast diagnostic imaging with magnetic resonance imaging (MRI) in unselected patient populations have exposed a number of pitfalls that threaten well-established, data-proven medical practice.

The use of oral oncolytics is increasing, with 14 approved already and nearly one-quarter of the oncology pipeline consisting of oral therapies. Despite this, the Community Oncology Alliance (COA), a nonprofit organization that advocates for patients and providers in the community oncology setting, said many patients still have difficulty getting access`to targeted oral oncolytics.

The potential federal healthcare overhaul engendered a bitter debate over rumored "death panels" making end-of-life decisions for patients. Although the claims were never substantiated, the furor directed the nation's attention to the important issue of end-of-life care.

The December issue of Oncology & Biotech News featured highlights from the 51st American Society of Hematology (ASH) Annual Meeting and Exposition. We wrap up our ASH coverage this month with interviews on multiple myeloma with Brian G.M. Durie, MD, medical director and co-founder of the International Myeloma Foundation; chronic lymphocytic leukemia (CLL) with Robert J. Kreitman, MD, from the National Cancer Institute; and chronic myeloid leukemia (CML) with Francis J. Giles, MD, Cancer Therapy and Research Center at The University of Texas Health Science Center in San Antonio.

Participation in clinical trial research is essential to continued improvement in cancer care. Yet, fewer than 10% of U.S. adults enroll in trials. A recent US Oncology�sponsored survey found that most oncologists remain optimistic about the future of clinical trial research. We discuss obstacles to clinical trial enrollment with Nicholas Vogelzang, MD, and Matthew Galsky, MD, of the Comprehensive CancerCenters of Nevada.

The Third Annual Interdisciplinary Prostate Cancer Congress (IPCC) will take place on Saturday March 27, 2010, in New York City.

A persistent concern about using marijuana for medical purposes has been the lack of clinical trials demonstrating marijuana's effectiveness in any of the conditions for which it is legally prescribed in many states. Now, a team of researchers from the University of California San Diego School of Medicine's Center for Medicinal Cannabis Research (CMCR) has presented a summary of studies to the California legislature that claims smoking marijuana relieves pain in several chronic illnesses.

On January 29, the FDA expanded indications for lapatinib (Tykerb) to include its use in combination with the aromatase inhibitor letrozole (Femara) to treat hormone-positive and HER2-positive advanced breast cancer in postmenopausal women.

New data suggest that women who take aspirin regularly following a breast cancer diagnosis cut their risk of death and distant metastases by nearly 50%.

Healthcare reform (HCR) is complicated, not only because of the diversity of options but also the range and passion of opinions on the subject. Physicians are in the unique position of being able to see the debate from multiple angles. Yet, it does not take a physician to recognize that the current healthcare system is unsustainable.

In post-Katrina New Orleans, Louisiana, people refer to their return home and the revival of the city as �being back.� Today, the human spirit is thriving in the Big Easy�s resurrected communities and New Orleans is growing. The Tulane Cancer Center (TCC) at Tulane University Medical School has been the beneficiary of some of that growth.

In a phase III study of 1052 patients, nanoparticle albumin-bound (nab) paclitaxel (Abraxane)produced significant improvement in the overall response rate compared with standard paclitaxel in the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC).

In early February, Clarient Inc announced the commercial launch of its Insight Dx Pulmotype test that helps pathologists classify specific types of lung cancer so physicians can prescribe the most effective therapies.

Research and development in cancer has made a seismic shift toward immunotherapies, like anticancer vaccines, and the resulting tremor can be felt in the hallways and laboratories of drug and biotechnology companies large and small.

To help address delays in nuclear imaging procedures caused by an isotope shortage that resulted when two Canadian reactors went offline in 2009, the Academy of Molecular Imaging and other professional societies urged CMS to grant coverage for the use of NaF-18 PET in diagnosing bone metastases in patients with cancer.

A study presented at the ASCO 2010 Genitourinary Cancers Symposium found that adding urine testing to cystoscopy to monitor patients for bladder cancer recurrence greatly increases costs without a corresponding clinical benefit.

In February 2010, the FDA announced it would be developing and implementing stringent measures to regulate patient exposure to radiation associated with imaging studies, in particular from computed tomography (CT) scanning.

According to a study presented at the Society of Gynecologic Oncology 41st Annual Meeting on Women's Cancer, held in San Francisco, California, a combination of docetaxel(Taxotere) and carboplatin almost doubled progression-free survival (PFS) in patients with recurrent, platinum-sensitive ovarian cancer.