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Weekly Drug News Round-Up: December 16, 2015

Bridion Approval Launches New Drug Class

Clinicians should be aware of the possibility of anaphylactic reactions with Bridion Read More...

Neuromuscular blocking drugs cause temporary muscle paralysis and are used to facilitate endotracheal intubation, prevent movement during surgery, and during mechanical ventilation. This week, the FDA approved Merck’s Bridion (sugammadex), a novel selective relaxant binding agent (SRBA) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. In Phase 3 clinical trials of over 450 patients, recovery time was faster overall for the Bridion treatment groups compared to the comparator groups, with most participants recovering within 5 minutes of routine use of Bridion. Of the 299 participants treated with Bridion, one person had an anaphylactic reaction.

Vistogard Approved for Treatment of Certain Cancer Drug Overdoses

Fluorouracil (5-FU) and capecitabine are older cancer drugs used for breast and stomach cancers Read More...

It’s rare that an overdose of chemotherapy could occur, but toxicity can be fatal. Vistogard (uridine triacetate), by Wellstat Therapeutics, an oral pyrimidine analog, was approved by the FDA this past week for emergency treatment of adults and children who receive an overdose of fluorouracil (5-FU) or capecitabine, or who have severe or life-threatening toxicities within four days of receiving these drugs. In clinical studies in those treated for overdose or toxicity, 97 percent and 89 percent, respectively, were still alive at 30 days.

FDA Approves Alecensa for ALK-Positive Non-Small Cell Lung Cancer

ALK gene mutations are present in about 5 percent of patients with NSCLC Read More...

The FDA has approved Genetech's Alecensa (alectinib), an oral anaplastic lymphoma kinase (ALK) inhibitor for the treatment of people with ALK-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Xalkori (crizotinib). In two clinical trials, patients received Alecensa twice daily. Roughly 38 to 44 percent of patients experienced a partial shrinkage of tumors lasting on average 7.5 to 11.2 months. Sixty-one percent of patients who had measurable brain metastases saw a complete or partial reduction in their brain tumors lasting an average of 9.1 months.

Otiprio Cleared for Pediatric Tympanostomy Tube Placement Surgery

Otiprio provides sustained-exposure of ciprofloxacin so that a single administration provides a full course of treatment Read More...

Ear tubes are placed in children to treat ongoing ear infections or inflammation to help ventilate the middle ear and allow instillation of topical antibiotics. The FDA has approved Otiprio (ciprofloxacin otic suspension), a single-dose, fluoroquinolone antibacterial instilled by the surgeon in children with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative dose of Otiprio reduced a significant number of treatment failures compared to tubes alone. Otiprio is expected to launch in the first quarter of 2016.

Bendeka: Orphan Cancer Drug Approved for CLL and NHL

Bendeka should be commercially available to prescribers during the first quarter of 2016 Read More...

This past week the FDA approved Teva’s Bendeka (bendamustine hydrochloride) for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab (Rituxan) or a rituximab-containing regimen. Bendeka is a low-volume, 10-minute infusion formulation of bendamustine. Treanda is another bendamustine formulation, also approved for CLL and NHL, that requires a 30-minute infusion.