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Weekly Drug News Round-Up: January 27, 2016

Opdivo Plus Yervoy Gains Added Approval for Late-Stage Melanoma

Previously, approval for the combo only included the BRAF V600 wild-type mutation Read More...

The U.S. Food and Drug Administration (FDA) has expanded approval for the blockbuster anti-PD-1 antibody Opdivo (nivolumab) in combination with CTLA-4 inhibitor Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. Opdivo is also now approved as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. Median progression-free survival was statistically significant at 11.5 months for Opdivo/Yervoy regime, compared to 6.9 months for Opdivo monotherapy, and 2.9 months for Yervoy monotherapy. Fatigue, rash, and diarrhea were some of the common side effects reported in the CheckMate-067 trial.

New Kyprolis Combo Therapy Wins Approval for Multiple Myeloma

Multiple myeloma is an incurable blood cancer

The FDA has approved Kyprolis (carfilzomib) in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three treatments. The FDA also fully approved Kyprolis (from the previous 2012 accelerated approval) as a single agent for multiple myeloma. In the Phase-3 ENDEAVOR study, patients receiving Kyprolis and dexamethasone achieved a progression-free survival of 18.7 months compared to 9.4 months in those receiving bortezomib plus dexamethasone. Common reported side effects in the Kyprolis arm included anemia, diarrhea, shortness of breath, fatigue, insomnia, fever and low platelets.

Botox Approved for Lower Limb Spasticity

Spasticity is usually caused by damage to the portion of the brain or spinal cord that controls voluntary movement Read More...

Botox (onabotulinumtoxinA) is a neurotoxin complex indicated for the treatment of many conditions, including cervical dystonia, severe primary axillary hyperhidrosis (underam sweating), upper limb spasticity, and overactive bladder. This past week the FDA also approved Botox to treat adult lower limb spasticity to reduce the severity of increased muscle stiffness in ankle and toe muscles. Botox is the first approval to treat spasticity of multiple muscle groups of the upper and lower limbs. Phase 3 clinical trials demonstrated effectiveness to positively impact lower limb spasticity following stroke. Side effects included joint pain, back pain, muscle pain, and injection site pain.

Dalvance: New Dosing Regimen FDA-Approved for Antibiotic

Over 750,000 hospital admissions were attributed to acute bacterial skin infections in 2011 Read More...

Dalvance (dalbavancin) is an injectable antibiotic used for the treatment of acute bacterial skin and skin structure infections (ABSSSI), such as those caused by methicillin-resistant Staphylococcus aureus (MRSA). This past week, the FDA approved a new dosing regimen for Dalvance, as a single intravenous (IV) dose given as a 30-minute infusion. In Phase 3 studies, a single 1500 milligram (mg) dose of Dalvance was as effective at 48 to 72 hours after treatment as the two-dose regimen of Dalvance (1000 mg followed one week later by 500 mg). The one-time 30-minute infusion in a clinic or emergency setting may help to prevent hospitalizations or loss to follow-up.

Which Stop-Smoking Agent Works the Best?

As a New Year’s resolution, many smokers decide to quit smoking Read More...

Quitting smoking might mean going cold turkey, using group support, or drug or nicotine replacement therapy like the nicotine patch (Nicoderm CQ), the drug Chantix, or a combination of the patch and lozenges. But which is best? A new study this week in the Journal of the American Medical Association has data to show all three drug methods work equally well. At six months, the quit rate was 23 percent for the patch, 24 percent for Chantix, and 27 percent for the combination of patch and lozenges; however, Chantix was associated with more frequent side effects. Added benefit may be seen with a strong will to quit and group support.