FDA approves Genentech’s Perjeta for early-stage breast cancer
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.
The FDA announced the approval of Genentech’s Perjeta (pertuzumab) for the new usage, known as neo-adjuvant breast cancer treatment. The drug was already approved last year for certain breast cancers that had spread to other parts of the body. The new usage is intended for patients with breast cancer that includes increased amounts of the HER2 protein — as 20% of breast cancer cases do — whose disease is locally advanced and who are at high risk of the cancer spreading elsewhere in the body.
"We are seeing a significant shift in the treatment paradigm for early-stage breast cancer," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences."
SoloHealth survey finds widespread lack of awareness about health insurance marketplaces
SANTA CLARA, Calif. — Most consumers have "no" or "a little bit" of knowledge about the health insurance marketplaces set to open on Tuesday, according to a new survey.
Kiosk maker SoloHealth announced the results of the survey at the Health 2.0 conference in Santa Clara, Calif., showing little or no awareness among 64% of respondents. Fifty-six percent didn’t know before taking the survey that the government may pay for a portion of insurance for those who qualify, and 60% of those surveyed who have insurance don’t know how the law will affect them, along with 53% of those without insurance. The survey was conducted among 13,600 people through SoloHealth Station kiosks at 3,200 retail locations around the country from Sept. 12-22.
The company recently formed a partnership with the Department of Health and Human Services to help promote awareness and information around the new insurance marketplaces and Healthcare.gov. It also has partnerships with insurance providers to link potential buyers with plans to help consumers make appropriate decisions for their insurance needs.
FDA approves UCB’s Cimzia for psoriatic arthritis
BRUSSELS — The Food and Drug Administration has approved a new usage for a drug made by UCB, the drug maker said Monday.
UCB announced the approval of Cimzia (certolizumab pegol) for psoriatic arthritis in adults. Psoriatic arthritis is an inflammatory, autoimmune condition that causes pain, swelling and stiffness around the joints, usually combined with the skin lesions of psoriasis. The drug was already approved to treat rheumatoid arthritis and Crohn’s disease.
"The FDA’s approval of Cimzia for the treatment of active PsA provides an additional, effective treatment option for those living with the condition," director of rheumatology research at the Seattle-based Swedish Medical Center and University of Washington medicine professor Philip Mease said.