7 in 2011: A Short List of Drugs to Watch

From tiny biotech firms to giant pharmaceutical companies, the oncology drug development pipeline is pulsing with activity. There are nearly 900 potential new medicines and vaccines to treat cancer under study in the United States, according to the Pharmaceutical Research and Manufacturers Association of America. These include 122 for lung cancer, 107 for breast cancer, 70 for colorectal cancer, and 103 for prostate cancer. Considering the complexity of the clinical trials process, predications about which drugs will gain the FDA’s approval can stymie even the best industry analysts. Here, then, is a look at 7 oncology drugs that you’ll hear about this year, with no predictions about how they will fare in the regulatory process.

1. 1 New Date for Vandetanib The FDA is continuing its review of vandetanib (Zictifa), a tyrosine kinase inhibitor intended for the treatment of patients with unresectable locally advanced or metastatic medullary thyroid cancer. AstraZeneca said the agency extended its decision date from January 7 to April 7 in order to review a proposed risk evaluation and mitigation strategy the company was required to submit as part of the process.
2. Ipilimumab Decision Anticipated The FDA’s impending decision on Bristol-Myers Squibb’s promising new melanoma drug ipilimumab (Yervoy) remains a matter of great anticipation in clinical and industry circles. The agency had postponed a decision on the drug until March 26 in order to review additional information it had requested, the company announced in November. The FDA’s Oncologic Drugs Advisory Committee was scheduled to consider the drug at a February 9 meeting, but the meeting was canceled because the agency said it had resolved the scientific issues the panel was supposed to consider.
3. More Indications Sought for Fusilev A ready-to-use formulation of Fusilev (levoleucovorin) for injection would be available to treat patients with advanced metastatic colorectal cancer if the FDA approves a supplemental new drug application submitted earlier this month. Spectrum Pharmaceuticals anticipates agency action by April 29. Fusilev, now available as freeze-dried powder, is approved as rescue therapy for osteosarcoma patients who have been treated with high doses of methotrexate and to diminish the toxicity of methotrexate. The new formulation does not have to be reconstituted and is of higher strength than the currently approved version, a company official said in a press release.
4. Avastin Battle Not Over Yet Genentech Inc is asking the FDA for a hearing on the agency’s plans to disallow the metastatic breast cancer indication on the label for Avastin (bevacizumab). The company, a member of the Roche Group, said patients have been relying 8 / 01.11 upon the drug for 2 years, and that the European Medicines Agency reached a different conclusion than the FDA after examining the same data. Genentech filed a detailed response on January 18. In December, the FDA said the breast cancer indication should be removed because studies showed the overall survival and disease progression benefits do not outweigh serious adverse effects. The label indication for metastic HER2-negative breast cancer remains in place during the appeal. Avastin gained accelerated approval as a breast cancer treatment in 2008. Since 2004, Avastin has been approved for patients with colorectal cancer, non- small cell lung cancer, glioblastoma, and renal cell carcinoma.
5. Iniparib Staying on Fast Track Sanofi-aventis intends to file regulatory submissions within the next several months for iniparib (BSI- 201), a PARP inhibitor that has been on the FDA’s fast track as a treatment for women with metastatic triple-negative breast cancer (mTNBC). The company reported final phase II data earlier this month, saying submissions are planned in the United States during the first quarter and with the European Union later this year. The drug is in phase III trials for mTNBC and squamous non-small cell lung cancer, and phase II trials for ovarian, uterine, and brain cancers. Sanofi-aventis research center in Strasbourg, France.
6. Lymphoma Drug Application in the Works Key findings from a phase II clinical trial of brentuximab vedotin (SGN-35) for patients with relapsed or refractory systemic anaplastic large cell lymphoma generated excitement in research circles in December. Seattle Genetics, Inc said it plans to submit a biologics license application to the FDA during the first quarter this year. Millennium: The Takeda Oncology Company, which is developing the drug in a collaboration with Seattle Genetics, has started similar discussions with the European Medicines Agency.

1. Progress Reported on Blood Cancer Drug The oral drug INCB18424 demonstrated positive results in a pivotal phase III clinical trial for the treatment of myelofibrosis, a blood cancer that compromises bone marrow, the Incyte Corporation said earlier this month. The company said plans are in the works to submit a new drug application to the FDA by July. The drug, which works by inhibiting JAK enzymes, is being developed under a special protocol assessment designed to expedite the approval process.

FDA Updates New Drug for Cancer Pain Approved Abstral (fentanyl), an opioid analgesic administered in fast-acting transmucosal tablets, has been approved for cancer patients aged ≥18 who already use opioid pain medication around the clock and are experiencing periodic breakthrough pain. The FDA, in its January 7 approval notice, said the drug will be available only through healthcare professionals and pharmacies registered in the agency’s risk evaluation and mitigation strategy (REMS) program. The ProStrakan Group plc expects to launch Abstral by April, according to Orexo, a Swedish company partnering with ProStrakan. http://hcp.lv/ib5Eeu

Gardasil Approved to Prevent Anal Cancer The list of ways in which Gardasil can be used to battle the human papillomavirus (HPV) grew in December with the FDA’s approval of the vaccine as a means of preventing anal cancer and precancerous lesions due to HPV in people aged 9 through 26. The vaccine was found to be 78% effective in a randomized, controlled trial of men who self-identified as having sex with men, the agency said in its December 22 approval announcement. Gardasil, a Merck & Co, Inc product initially approved in 2006, is indicated for the prevention of cervical, vulvar, and vaginal cancer, as well as precancerous HPV-related lesions in women. It also is approved for the prevention of genital warts caused by 2 HPV strains in men and women. http://hcp.lv/fhSXNx

3 Oncology Diagnostic Devices Gain Support The Center for Devices and Radiological Health has approved a test that can measure overexpression of the HER2 gene, a mammography system, and an enhanced bladder cancer diagnostic method.

HER2 FISH pharmDxTM employs a fluorescent in situ hybridization (FISH) method to determine whether too many copies of the HER2 gene are present in gastric cancer patients who are under consideration for treatment with trastuzumab (Herceptin). Dako Denmark A/S is bringing the test to market. http://hcp.lv/gtSR6z

The KODAK DirectView CR Mammography System consists of a cassette that fits into standard KODAK mammography x-ray equipment and converts latent images captured by laser scanning into final digital images that it then processes for analysis and archiving. Carestream Health, Inc developed the product. http://hcp.lv/g3uY3V

The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System is designed to improve the detection of nonmuscle invasive papillary cancer of the bladder. The system, which transmits blue light through a fluid cable connected to an endoscope, functions as an optional add-on to be used in combination with the diagnostic imaging drug Cysview,® according to the FDA. Developed by Karl Storz Endoscopy-America, Inc, the system includes a light source, cable, cystoscopes, and a camera. http://hcp.lv/gfYFZG 10 / 01.11

Web Resources Getting Up to Speed on Information Technology If you want to keep track of the federal government’s push to expand health information technology, check out the updates that David Blumenthal, MD, MPP, posts on the US Department of Health and Human Services’ Website. Blumenthal, national coordinator for health information technology, summarized 4 major programs now underway in a December 10 posting that links to more detailed reports on each area. It has been nearly 2 years since the Health Information Technology for Economic and Clinical Health (HITECH) Act was signed into law. http://hcp.lv/esLfbl

NCCN Expanding Patient-Friendly Materials The National Comprehensive Cancer Network (NCCN) is rapidly building its library of guideline materials developed specifically with patients, their loved ones, and caregivers in mind. The NCCN Guidelines for PatientsTM series debuted in September with consumer-friendly versions of the breast and lung cancer guidelines that form the standard of care for oncology professionals. The list of booklets has now been expanded to separate guides for melanoma, multiple myeloma, ovarian cancer, and prostate cancer. The organization plans to publish patient versions of guidelines for all major adult cancer sites eventually. http://hcp.lv/gLyYaZ

Taking a Bow Meeting the Gold Standard CEO Cancer Gold StandardTM accreditation, which recognizes corporate efforts to battle cancer in workplaces, was conferred upon 6 companies and institutions in December. Those awarded the designation initiated programs to promote healthy lifestyle choices among employees and their families, as well as access to quality care and clinical trials once a cancer diagnosis is made. The CEO Roundtable on Cancer is a 10-year-old organization that has established a process where companies are required to meet cancer-fighting standards to receive the accreditation. Honored were: Dell Inc, Round Rock, Texas; Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota; Cancer Prevention and Research Institute of Texas, Austin; Logistics Health, Inc, La Crosse, Wisconsin; United Health Services Hospitals, Binghamton, New York; and Vassar Brothers Medical Center, Poughkeepsie, New York. www.cancergoldstandard.org onclive.com Check Up

In the News Chronic Disease Patients Embrace Health-Related Social Networking People living with chronic diseases, including cancer, are far less likely than healthy adults to spend time on the Internet. But when they do venture online, these patients are particularly likely to get involved with blogging and online health discussions. Those were among the insights in the Cancer 2.0: A Summary of Recent Research that the Pew Research Center published in December. The Washington, DC-based foundation drew from a variety of studies to paint a picture of the ways in which cancer patients use the Internet. In general, cancer patients are skeptical of getting information about their disease from Internet sources. A National Cancer Institute survey found that the public’s “trust in information from healthcare professionals had increased while their trust in health information from the Internet had waned” between 2002 and 2008, according to the Pew report. Overall, 81% of healthy adults report going online while a comparatively lower 62% of people living with 1 or more chronic diseases report doing so, the Pew study said. Regardless of their health status, though, 8 of 10 Internet users look for health information. And, the Internet is a potent force for cancer patients. The report said social networking activities are attractive to people living with chronic diseases and offers suggestions for ways in which healthcare providers can guide discussions. “The online conversation cannot be controlled, but trusted sources can contribute by making it easy for Internet users to find and share up-to-date information,” the researchers said. “For example, instead of publishing only in PDF, organizations can publish in a way that allows someone to grab a chart, a data point, or an image and link back to specific part of a document. Publicly available data sets can also be posted in computable formats.” To read the full report, visit http://hcp.lv/hgRC9u

Need a Reason to Improve Your Health? There’s Evidence for These Resolutions It’s not too late to make New Year’s resolutions and, if you need an excuse to put healthy lifestyle choices on your list, the University of Buffalo (UB) has advice from the experts. The school, part of the State University of New York system, has 10 research-based resolutions posted on its Website—along with the studies conducted by university researchers that back up the suggestions. UB researchers found that eating more soy products may reduce the risk of developing breast cancer, getting 7 hours of sleep might decrease the risk of developing diabetes, and paying cash at the grocery store might lead to fewer junk food purchases. www.buffalo.edu/news/12128 12 / 01.11 Source: Fox S, Purcell K; Pew Research Center. Chronic disease and the Internet. www.pewinternet.org/Reports/2010/Chronic-Disease.aspx. Published March 24,2010. Accessed January 18, 2011.

Americans Are Buying Prescription Drugs From Rogue Online Pharmacies in Droves More Americans are turning to illegal Internet pharmacies to purchase prescription drugs, according to a new survey by the Partnership at Drugfree.org. The survey found that 36 million patients, or 1 in 6 adults, purchased medications online without a prescription. The new data were released in December at the White House Intellectual Property Health and Safety Forum. The survey was funded by the Alliance for Safe Online Pharmacies (ASOP), whose members include the American Pharmacists Association and the National Association of Chain Drug Stores. According to ASOP, more than 95% of Internet organic search results lead patients to rogue online sellers peddling unapproved and potentially counterfeit medicine—without a prescription. Experts say more must be done to educate patients about the dangers of patronizing these fraudulent businesses. “Consumers need to understand that the products they receive from Internet drug sellers are often not the same, FDA-approved medicine that they could get from a legitimate pharmacy. Products sold on rogue Web sites may be ineffective, harmful, or worse,” said Libby Baney, an advisor to ASOP. To curb the practice, ASOP is partnering with a voluntary task force of 11 major Internet commerce companies, including American Express, Microsoft, Google, PayPal, and Yahoo!. The newly formed nonprofit group aims to shut down rogue sites and provide patients with legitimate channels for buying drugs online.

HCPLive Highlights Intellisphere, the parent company of Oncology Net Guide and a family of medical publications, offers a wealth of news and information for oncology and other healthcare professionals on its Website, www. HCPLive.com. Here are a few highlights: Scenes From the Radiology Archives Care to share an interesting echocardiography video? Echojournal, an online ultrasound video sharing site, is available round- the-clock through the HCPLive Network. Registered users are invited to upload and discuss videos (edited, of course, to protect the privacy of patients). One recent addition, for example, depicts the coarctation of the aorta, complete with sound. The site offers complete social networking functions, including the ability to make friends, follow the video feeds of individuals or departments, and join in discussions. The site is intended for current and future physicians and healthcare professionals who use echocardiography in their practices. http://hcp.lv/eQOM0x Pharmacy Times Puts Focus on Helping Patients With Venous Thromboembolism The risks that cancer patients face from venous thromboembolism (VTE) has been a widely studied aspect of oncology care. Pharmacy Times is offering a free, online refresher course on managing VTE called “Venous Thromboembolism and Cancer: An Opportunity for Pharmacists to Optimize Care.” Rowena N. Schwartz, PharmD, BCOP, director of Oncology Pharmacy, The Johns Hopkins Hospital, Baltimore, Maryland, developed the VTE course as a continuing medical education program for pharmacists, and any healthcare professional with an interest in the subject would benefit from the overview. The course includes several case studies. http://hcp.lv/hu5Jfu Webinars Offer Tips for Physicians on Practical Uses of Technology If you’d like to listen to experts on a variety of technology topics, check out the Webinars offered on HCPLive. One popular entry is a discussion by Don S. Dizon, MD, FACP, an early iPad adopter and HCPLive blogger, about the benefits of using the iPad and apps that are particularly useful for healthcare professionals. Other topics include a debate about small versus large vendors for electronic health records and integrated marketing planning both online and offline. The content is free to registered users—and registration is also free! For details, visit www.hcplive.com/webinars.