FDA approves new medullary thyroid cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.
The FDA announced the approval of Cometriq (cabozatinib) to treat medullary thyroid cancer — a cancer that develops in cells in the thyroid gland that make calcitonin, a hormone that helps maintain a healthy level of calcium in the blood — that has spread to other parts of the body. Another drug to treat medullary thyroid cancer, AstraZeneca’s Caprelsa (vandetanib), was approved last year.
"Cometriq is the second drug approved to treat medullary thyroid cancer in the past two years and reflects the FDA’s commitment to the development and approval of drugs for treating rare diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Prior to today’s approval and the approval of Caprelsa in April 2011, patients with this rare and difficult-to-treat disease had limited therapeutic options."
The National Cancer Institute estimated that 56,460 Americans will be diagnosed with thyroid cancer — and 1,780 will die from it — in 2012.
User fee re-authorization fuels generics’ outlook
Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”
The enactment in July of the Prescription Drug User Fee Act, or PDUFA, which by law must be re-authorized every five years, provides the Food and Drug Administration with much of the funding the agency needs to review and approve manufacturers’ new-drug applications.
This year, for the first time, the law included Generic Drug User Fee Amendments, thus creating a system of user fees for generic drug companies. The fees, which are projected to raise about $299 million per year over five years, will go toward hiring extra staff to help clear the agency’s estimated backlog of 2,500 generic drug approval applications awaiting review.
The new funding also will spur development of bioengineered and biosimilar medicines by providing the FDA “with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation,” according to Castellani.
Telemedicine, mhealth apps gain ground
New applications based on advances in telemedicine and mobile health technology are proliferating as pharmacy providers, physicians and health plans find new ways to connect with patients who are homebound or in remote locations. The result is to extend access to care, improve convenience and lower health delivery costs.
Drug chain innovators like Thrifty White have offered prescription dispensing and telemedicine services for years to reach patients far from a brick-and-mortar store with pharmacy services, using either a kiosk or a pharmacy technician linked in real time via a live monitor to a pharmacist at a “hub” location. More recently, advances in mobile health applications for computers, remote site kiosks and smartphones have extended the ability of pharmacies and other health providers to reach patients where they live and work.
This fall, telemedicine and mobile health, or mhealth, applications reached another crescendo. Walgreens’ Take Care Health Systems announced a new collaboration with Blue Cross and Blue Shield of North Carolina. Called OnlineCareNC, the new collaborative service allows BCBSNC members to receive a telehealth consultation from a Take Care nurse practitioner, health coach or nutritionist via two-way video, secure text chat or phone.
Almost simultaneously, two other technology providers expanded their own mobile health commitments. SoloHealth unveiled plans to expand its FDA-approved SoloHealth Station health-and-wellness digital kiosks to more than 2,500 store locations by mid-2013 on the way to more than 4,000 locations by 2014. And kiosk maker PharmaSmart said it was partnering with the U.S Centers for Disease Control and Prevention’s “Team Up. Pressure Down.” program to promote blood pressure management among patients with hypertension.