The gist: With a stamp of approval from the U.S. Food and Drug Administration (FDA), doctors in the U.S. are now free to prescribe a new treatment to combat nausea and vomiting caused by chemotherapy. The treatment combines the drugs netupitant and palonosetron (Akynzeo). Akynzeo was approved on its own in 2008, and netupitant is a new drug. Clinical trials have shown that the combo works better than Akynzeo alone.
“The Food and Drug Administration (FDA) is looking to speed up the approval process for chemotherapies and other cancer drugs to treat early-stage breast cancer, the agency announced Monday.
“In a guidance document, the FDA said it is looking to expedite the approval process to encourage industry to develop breakthrough chemotherapies, formally known as neoadjuvant treatment.
“The guidelines are intended to help pharmaceutical companies design trials that will get approved more quickly so they can begin marketing the breast cancer therapies before they’ve completed testing, the FDA noted.”
“A US Food and Drug Administration (FDA) advisory committee voted October 1 not to recommend approval, at least for now, of a high-intensity focused ultrasound (HIFU) device to treat some patients with recurrent prostate cancer.
“Members of the Gastroenterology and Urology Devices Panel of the FDA’s Medical Devices Advisory Committee encouraged the device manufacturer to continue to conduct research but to come back when the ongoing pivotal trial at 20 sites in the United States and Canada is completed, not halfway through.
“SonaCare Medical Devices of Charlotte, North Carolina, had requested FDA approval of its Sonablate 450, a computer-controlled device with a probe that clinicians can use to deliver HIFU energy through thermal ablation to the prostate. The proposed indication was for treatment of biopsy-proven recurrent cancer in patients, low to high risk, who have failed primary external beam radiation therapy and have prostate-specific antigen (PSA) readings lower than 10 ng/mL.
“SonaCare based its request on an interim analysis of results from a nonrandomized, single-group clinical trial involving the first 100 of a planned 200 patients. Patient ages ranged from 53 to 83 years (mean, 69.7 years), they were mostly white (76%), and they had pretreatment PSA readings ranging from 0.4 to 14 (mean, 4.9).
“Of the first 100 patients enrolled at 16 sites, 78 completed 12 months of follow-up and had a biopsy, and 22 did not.”
The gist: When a newly developed drug for a rare (“orphan”) disease seems particularly promising for patients, the U.S. Food and Drug Administration (FDA) may choose to grant it “orphan drug designation.” The designation removes certain barriers that might otherwise keep a drug company from being able to successfully develop and profit from the drug in the U.S. A new drug called aldoxorubicin has just received an orphan drug designation for the treatment of small cell lung cancer (SCLC), glioblastoma multiforme, and ovarian cancer. Aldoxorubicin is a special version of the chemotherapy drug doxorubicin. It allows for higher doses of doxorubicin with fewer side effects.
“The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designations to aldoxorubicin in three indications: glioblastoma multiforme, small cell lung cancer, and ovarian cancer. Aldoxorubicin combines doxorubicin with a novel single-molecule linker that binds directly and specifically to albumin, allowing greater doses of the chemotherapeutic agent to be administered while reducing its toxic side effects.
“Aldoxorubicin is currently being studied in a global phase III clinical trial evaluating the efficacy and safety of aldoxorubicin as a second-line treatment for patients with soft-tissue sarcoma. CytRx, a biopharmaceutical research and development company, is also evaluating aldoxorubicin in two phase II clinical trials, one in patients with late-stage glioblastoma multiforme and the other in HIV-related Kaposi’s sarcoma. A global phase IIb trial in patients with relapsed small cell lung cancer is expected to commence later this month, and the company is undertaking a phase Ib combination study of aldoxorubicin plus gemcitabine as a potential precursor to a trial in relapsed ovarian cancer.”