A combination of lapatinib, trastuzumab, and paclitaxel significantly improved tumor response rates in patients with HER2-positive breast cancers, according to a new study presented at the annual Cancer Therapy and Research Center-American Association for Cancer Research San Antonio Breast Cancer Symposium held recently in San Antonio, Texas.
FDA is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.
Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing their propoxyphene-containing products from the market as well.
In a multinational, placebo-controlled, double-blind trial, the selective vitamin D receptor activator paricalcitol (Zemplar, Abbott Laboratories), at doses of 1 µg or 2 µg daily, reduced albuminuria in patients with type 2 diabetes, who were already being treated with renin-angiotensin-aldosterone system inhibitors.
Canada-based Theratechnologies announced that FDA has approved tesamorelin (Egrifta) to treat HIV patients with lipodystrophy. The condition is associated with many antiretroviral drugs used to treat HIV.
Metformin, either alone or in combination with sulfonylurea, appears to increase 1-year and long-term survival in patients with type 2 diabetes mellitus and chronic heart failure, according to research published in the October 1 issue of the American Journal of Cardiology, HealthDay News reported.
An FDA panel has recommended that the agency approve Orexigen Therapeutics' and Takeda's obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.
Nonanthracycline-containing chemotherapy regimens for the adjuvant treatment of operable stage I to III breast cancer are discussed, including efficacy and toxicity results from recent randomized clinical trials comparing anthracycline to nonanthracycline-containing regimens.
FDA voted today against approving 2 drugs for the prevention of prostate cancer: finasteride (Proscar, Merck) and dutasteride (Avodart, GlaxoSmithKline).
Focus on 2010: A year of novel pharmacologic agents in review; Azilsartan: A next-generation angiotensin II receptor blocker for the treatment of hypertension; Agents in late-stage development for the treatment of eye diseases
Agents in late-stage development for the treatment of eye diseases.
The commonly used pain reliever-acetaminophen-causes a significant increase in blood pressure in patients with pre-existing coronary artery disease, according to a randomized controlled trial published ahead of print in the October 18, 2010, Circulation.
Removal of marketed unapproved drugs (MUDs), such as that with oral colchicine, is part of FDA's Unapproved Drugs Initiative (launched in 2006).
Throughout 2010, Formulary's "Focus on" articles have examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics (P&T) committee members. Because many readers have said that they frequently refer to this column when making formulary decisions for hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each.
Patients with systolic heart failure and mild symptomatology [New York Heart Association class II] taking the mineralocorticoid receptor antagonist-eplerenone-experienced a 37% reduction in death from cardiovascular causes or first hospitalization for heart failure, researchers demonstrated in a new study.
The new House leaders are gearing up for a vote to repeal health reform early next year. Such a move, though, is expected to be largely symbolic, as it's unlikely to pass the Senate or to override Obama's veto pen.
New molecular entity: Fingolimod (Gilenya) has recently been approved by FDA to treat patients with relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Generic drugs approved by FDA (through November 2010): Zafirlukast tablets and Desloratadine tablets
Specialty pharmaceuticals are expected to eventually replace non-specialty agents for the management of various conditions, including gout, lupus, diabetes, and hypercholesterolemia.
Azilsartan medoxomil (TAK-491), the prodrug form of azilsartan (TAK-536), is an ARB under review for FDA approval for the treatment of hypertension.
Rivaroxaban, an oral direct Factor Xa inhibitor given once daily was superior to warfarin in reducing the risk of stroke and non-central nervous system systemic embolism in patients with AF, with comparable rates of bleeding in the pre-specified on-treatment population, according to results from the ROCKET AF study.
About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."
New molecular entity: Dabigatran etexilate (Pradaxa) was approved for stroke prevention in atrial fibrillation.
The outcomes associated with treating patients with chronic myelogenous leukemia improved dramatically when FDA approved imatinab. Subsequently, newer agents in the same therapeutic class have been approved, and early clinical studies suggest that they may become the new standard of care.
Recent FDA action (through, November 2010) related to Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502.
Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron
