Novartis’ Tasigna receives nod from FDA
SILVER SPRING, Md. The Food and Drug Administration has approved a drug as an early treatment for a rare form of blood cancer, the agency said Thursday.
The FDA approved Novartis’ Tasigna (nilotinib) for newly diagnosed Philadelphia chromosome positive chronic phase chronic myeloid leukemia, also called Ph+ CP-CML. The disease is a slowly progressing cancer of the blood and bone marrow resulting from a genetic abnormality. The agency originally approved Tasigna in 2007 for Ph+ CP-CML in adults whose disease had progressed or who could not tolerate other therapies, such as Gleevec (imatinib), also made by Novartis.
“It’s important for companies to continue developing oncology drugs for earlier stages of the disease once they have demonstrated clinical effectiveness in resistant forms of cancer,” FDA Center for Drug Evaluation and Research Office of Oncology Drug Products Richard Pazdur said. “This approach has the potential to increase the availability of an effective treatment to more patients.”
FDA approves Jevtana
SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for advanced prostate cancer, the agency said Thursday.
The FDA announced the approval of Sanofi-Aventis’ Jevtana (cabazitaxel), a chemotherapy drug used with the steroid prednisone. The agency said the drug was the first treatment for advanced, hormone-refractory prostate cancer that has worsened during or after treatment with docetaxel, also a chemotherapy drug used in advanced prostate cancer. Hormone refractory prostate cancer happens when prostate tumors continue to grow despite treatments meant to reduce the body’s production of the male hormone testosterone, which helps prostate tumors grow.
“Patients have few therapeutic options in this disease setting,” FDA Center for Drug Evaluation and Research Office of Oncology Products director Richard Pazdur said. “FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”
Report: Oregon State Board of Pharmacy declares marijuana as drug with medical use
SALEM, Ore. The makers of the 1930s documentary “Reefer Madness” would be furious at the news, but it likely will come as a relief to people with certain diseases and marijuana law-reform advocates.
The Oregon State Board of Pharmacy voted Wednesday to have marijuana classified as a drug with medical use, according to reports from a local TV station. The decision makes the state to reclassify it as such.
Under the decision, marijuana will be known as a Schedule II controlled substance, meaning that it has high potential for abuse but still has medical benefits. Previously — and still in all other states — marijuana was a Schedule I drug, meaning it had no medical benefits.