There's been a flurry of activity in recent weeks when it comes to oncology drug filings at the FDA. While every application is unique, the agency is required to decide within 60 days whether a new drug application (NDA) will move forward for a full review.
There’s been a flurry of activity in recent weeks when it comes to oncology drug filings at the FDA. While every application is unique, the agency is required to decide within 60 days whether a new drug application (NDA) will move forward for a full review.
The FDA’s Center for Drug Evaluation and Research seeks to review an NDA within 10 months at the latest and within 6 months for those applications granted priority status, according to agency policies.
Here are 5 drugs that have advanced through the clinical trials process to FDA filings since mid-December.
Promising Prostate Cancer Drug Under Review
Abiraterone acetate, which has generated much excitement in research circles as a treatment for metastatic advanced prostate cancer, was submitted for review under an NDA filing in December. The drug is an oral androgen believed to inhibit the key enzyme CYP17. Centocor Ortho Biotech Inc, Horsham, Pennsylvania, is seeking approval to market the drug for patients with castrate-resistant prostate cancer who have received prior chemotherapy containing a taxane.
Lung Cancer Therapy Gets Rolling
The NDA for crizotinib (PF-02341066), a first-in-class treatment for patients with advanced non-small cell lung cancer (NSCLC), is being submitted on a rolling basis after the FDA granted the drug fast-track status in December, said Pfizer Inc. The company, headquartered in New York City, anticipates completing the submission by July. Crizotinib, an oral compound, is an anaplastic lymphoma kinase (ALK) inhibitor for NSCLC patients whose tumors are ALK-positive.
New Step for Blood Cancer Treatment
Carfilzomib, a next-generation proteasome inhibitor, will be evaluated for approval under the fast-track designation for the treatment of patients with relapsed and refractory multiple myeloma. Onyx Pharmaceuticals, Inc plans to complete its NDA submission on a rolling basis by midyear. The Emeryville, California, company is developing carfilzomib under the orphan drug program. The drug also is being investigated as a first-line multiple myeloma treatment as well as in lymphoma and other cancers.
Approval Sought for New Vinorelbine Formulation
Exelbine (ANX-530) is under review as a novel emulsion formulation of the chemotherapy drug vinorelbine for the treatment of non-small cell lung cancer. Adventrx Pharmaceuticals, Inc said its formulation is aimed at reducing the incidence and severity of injection-site reactions patients experience with Navelbine, which has been approved since 1994, and its generic equivalents. The San Diego, California, company announced the NDA filing in January and expects the FDA to complete its review by September 1.
Leukemia Drug on Fast Track
A Norwegian drug development company is recruiting patients for a clinical trial of elacytarabine, a novel lipid-conjugated form of cytarabine for the treatment of patients with acute myeloid leukemia (AML), after the drug was granted fast-track status in December. Clavis Pharma, based in Oslo, said clinical trial results are expected during the second half of 2012, with regulatory filings to follow if findings are positive. Elacytarabine has been designated as an orphan drug by the FDA and the European Medicines Agency, the company said.
First Diagnostic Radiology App Approved
Physicians will be able to make a diagnosis based on what they see on their iPhone or iPad now that the FDA has given its seal of approval to a mobile radiology application for the first time. Mobile MIM, created by MIM Software Inc, enables physicians to analyze radiology images created in a hospital or office and transferred via a secure network to a portable wireless device.
The FDA said various devices were tested for luminance, image resolution, and noise before the Apple product was chosen. One important Apple feature is an interactive contrast test that allows the user to check the screen so the lighting conditions do not interfere with the ability to see subtle differences in images.
The FDA cleared the application for viewing images from computed tomography, magnetic resonance imaging, and nuclear medicine technology such as positron emission tomography. The agency said it is indicated for use when physicians are not able to access a workstation. For more information, visit http://tiny.cc/hz8f3.
Recall Warnings Intensify
The FDA is reminding healthcare professionals to check labels on prep pads to see whether the product is sterile or nonsterile in the wake of the recall of Triad pads and swabs potentially contaminated with Bacillus cereus, which can cause rashes and skin infections. The Triad pads are sold in retail pharmacies and are packaged in kits with certain injectable drugs. In January, The Triad Group of Hartland, Wisconsin, launched a voluntary recall of all lots of its alcohol prep pads, alcohol swabs, and alcohol swabsticks, including those products marked as sterile as well as nonsterile. The recall covers prep products Triad markets under its own label as well as 8 third-party manufacturers. For further information, check these sites:
A Setback for Development of Prostate Cancer Drug
An effort to extend the approved uses of Avodart (dutasteride) for reducing the risk of prostate cancer in men already deemed vulnerable faltered in January. GlaxoSmithKline said the FDA issued a complete response letter on its supplemental new drug application, meaning the approval process cannot move forward in its current form. The decision does not affect any currently approved uses for Avodart. The drug is indicated for treating symptomatic benign prostate hyperplasia (BPH) in men with an enlarged prostate, for reducing the risks of acute urinary retention, and for reducing the need for BPH-related surgery in combination with tamsulosin.
Rituxan Use Extended to Advanced Lymphoma
Rituxan (rituximab), a therapeutic antibody in use since 1997, is now approved as a first-line maintenance treatment for patients with advanced follicular lymphoma. The FDA based its January 28 decision on the Primary Rituxan and Maintenance (PRIMA) study, which showed that patients who responded to Rituxan plus chemotherapy nearly doubled their likelihood of progression-free survival if they continued on Rituxan therapy every 2 months for 2 years. The drug also is indicated in certain other lymphoma patients and rheumatoid arthritis. Genentech, a member of the Roche Group, is partnering with Biogen Idec in the United States.
Breast Implants Raise Concern of Link With Rare Lymphomas
The FDA is asking healthcare professionals to report confimed cases of anaplastic large cell lymphoma (ALCL) in women who have received breast implants in order to evaluate the risk the products might pose. Concerns about the association of saline and silicone gel-filled breast implants with ALCL surfaced after about 60 cases were reported worldwide. The numbers, however, have been difficult to verify, the FDA said. From 5 million to 10 million women worldwide have received breast implants. ALCL is a rare cancer diagnosed in about 1 of 500,000 women in the United States annually; it is diagnosed in only about 3 of every 100 million women without implants.
Walking While You Work
Consumers have long had their pick of gadgets that help promote healthy lifestyles. Now, a major health insurer is teaming up with an exercise equipment manufacturer to encourage office workers to make the most of their workday by going for a walk at their desks.
Aetna is offering its employer customers an opportunity to purchase the Details Walkstation at a discount through a partnership with the manufacturer, a division of Steelcase. The station includes a treadmill with a quiet motor and a maximum speed of 2 miles per hour and a desk that can be adjusted to the height of different users, the companies announced jointly in January. The treadmill controller measures speed, time, distance, and calories burned.
“I spend a lot of time on conference calls and even more time responding to emails and working on reports,” Paul Coppola, an employee in Aetna’s Hartford, Connecticut, headquarters, said in a press release. “When our department was testing the Walkstation, I jumped at the chance to use it. It was amazing how much more energy I had spending even 30 minutes a day walking and working on the Walkstation.”
Tech Pioneers on Parade at Digital Health Summit
At the 2011 International Consumer Electronics Show in Las Vegas, Nevada, innovators showcased new technologies that experts are calling “game changers” for digital health. The event’s Digital Health Summit, held January 7, focused exclusively on these technologies and their potential to transform healthcare.
The highlight of the summit, which was held in partnership with Microsoft, was a panel honoring several companies for advancements in the field. Participating firms included PhiloMetron, whose digital patch measures how many calories a person has eaten and burned, and Proteus Biomedical, developer of edible microchips that can be embedded in “smart pills” to provide biofeedback on a medication’s effectiveness.
The panel also featured a representative from Healthsense, creator of the eNeighbor Resident Monitoring system. The remote system collects vital health data and alerts caregivers to any changes in daily habits, such as sleeping, eating, or bathroom use. It can be customized to a patient’s individual risk profile, and has the potential to help seniors live more independently as they age.
Rounding out the product offerings was the bebionic, which stood out against some of the more consumer-oriented devices the summit featured. Created by Steeper, this flexible, lifelike bionic hand is backed by powerful software that offers precise motor control through grip patterns that can be customized.
Through this diverse mix of pioneering products, the panel offered thought leaders a chance to glimpse the future of health technology. “It’s an exciting time, and being able to bring these individuals together in one room to show, talk about, and demonstrate their various technologies is an opportunity I just couldn’t pass up,” said Jill Gilbert, co-producer of the summit.
Google Launches “Body Browser”
December brought the launch of Google’s “Body Browser,” a tool that delivers a 3-dimensional interactive map of the human body. Although the application received mixed reviews for functionality, many health providers agree that it holds promise as a visual aid for patients.
“Using Body Browser, you can explore different layers of human anatomy by moving the slider to rotate and zoom in on parts you are interested in,” Google wrote in an introduction. Users can search the map through anatomical terms and share the image they’re viewing by copying and pasting a URL.
The product is currently housed in Google Labs, which means it’s still in the experimental stages. To try the demo tool and provide Google with feedback on how to improve it, visit http://bodybrowser.googlelabs.com.
A Tall Order for Cancer Fundraising
How long would it take you to run up the stairs of 1 of the world’s tallest buildings? Thomas Dold of Germany scaled 86 flights of steps to the public observation deck—1050 feet in the air—in 10 minutes, 10 seconds to lead the field in the February 1 Empire State Building Run-Up race while Alice McNamara of Australia beat all women contestants with a time of 13 minutes, 3 seconds. The big winner, though, was cancer research. The Multiple Myeloma Research Foundation, partnering with the New York Road Runners to sponsor the 34th annual event, raised more than $250,000 through the race.