Accelerated Cancer Drug Approvals

The FDA is establishing a new and quicker pathway for getting promising cancer treatments to patients. Recently drafted regulatory guidance, published in The New England Journal of Medicine, describes an accelerated approval pathway—with a couple of restrictions. The drugs would have to be tested prior to the surgical removal of tumors and would only be for certain types of high-risk patients with a localized, early-stage cancer.
The approach is based on the design of the I-SPY 2 TRIAL, a Phase II breast cancer trial being conducted by the Biomarkers Consortium (a private-public partnership led by the Foundation for the National Institutes of Health that includes representatives from NIH, FDA, pharma companies, and academic research centers). In the I-SPY 2 TRIAL, biomarkers are used to select patients who are the most likely to benefit from the new approaches being tested. The researchers take into account the tumor profile of the patients and how they would benefit from a specific drug. This trial also allows new treatments to be tested in half the time, at a lower cost, and using fewer participants.
Under the new guidance, the FDA could approve new drugs that show a clinical benefit in patients receiving this “neoadjuvant” treatment and whose invasive cancer has already disappeared by the time of surgery. For instance, I-SPY 2 results paired with a follow-on phase III study examining the biomarker populations discovered in I-SPY 2 could be enough for accelerated approval.

mhealth Makes Headway in Emerging Markets

While mHealth is floundering domestically (and in most developed nations), it is flourishing in emerging markets, according to a new study, “Emerging Health: Paths for Growth,” conducted for PwC Global Healthcare by the Economist Intelligence Unit (EIU). According to the study, far more patients in emerging markets are em- bracing mHealth: 59% use at least one mHealth application or service compared with 35% of patients in the developed world. Doctors in emerging markets are also more enthusiastic—68% recommend patients use mHealth solutions compared to 59% in developed markets. (That figure jumps to 80% in India and China.)
The more rapid adaptation of mHealth in emerging markets may be driven out of necessity. There is a lower number of doctors per head in these countries and sometimes mobile technology is the only way to reach patients. Money is also an issue—53% of these countries’ patients name cost as a leading influencer behind its use. Additionally, for the most part, there is a lack of healthcare infrastructure and thus fewer barriers preventing change.
Source: Economist Intelligence Unit, 2012

A Medicinal Lullaby

The soothing power of a sweet lullaby can do more than just put a baby to sleep—it can help premature babies overcome their growth hurdles. The Pacifier Activated Lullaby (PAL), a medical device developed by Florida State University, uses lullabies to help infants learn the muscle movements needed to properly feed.
“Unlike full-term infants, very premature babies come into the world lacking the neurological ability to coordinate a suck/ swallow/breathe response for oral feeding. The longer it takes them to learn this essential skill, the further behind in the growth process they fall,” says Jayne Standley, Florida State’s Robert O. Lawton Distinguished Professor of Music Therapy and inventor of PAL.
The device teaches infants how to correctly suck through musical reinforcement. PAL is comprised of a specially wired pacifier and speaker that will play music as long as the baby continues the correct sucking motion. Studies have found that the device increases an infant’s sucking rate by two and a half and can reduce the hospital stay of a premature baby by an average of five days. PAL has received FDA approval, and FSU has partnered with Powers Device Technologies, Inc. to sell the device to hospitals around the world.


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