FDA Roundup: Newly Approved Treatment Options

Physicians should be aware of several new FDA approvals:

Avastin: Cervical Cancer

The FDA has approved Avastin (bevacizumab) for the treatment of recurrent or late-stage cervical cancer.

The drug works by disrupting blood vessels supplying cancerous cells, and was approved for use in combination with paclitaxel and cisplatin.

Avastin received a priority review because of its significant potential to improve treatment of the condition.

In a study of 452 participants with cervical cancer, patients taking chemotherapy drugs in combination with Avastin showed an increase in survival of 16.8 months, over 12.9 months in those taking chemotherapy alone.

The drug’s main side effects include fatigue, loss of appetite, hypertension, hyperglycemia, hypomagnesemia, urinary tract infections, and headache.

US Food and Drug Administration. FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer [press release]. August 14, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm410121.htm. Accessed August 19, 2014.

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Belsomra: Insomnia

Belsomra (suvorexant)—an orexin receptor antagonist— has been FDA-approved for the treatment of insomnia.

The drug works by altering the signaling of orexin (chemicals that regulate the sleep-wake cycle) in the brain. 

Patients are to take Belsomra tablets within 30 minutes of going to bed, and dosage should be limited to 20 mg daily. 

The drug’s safety and effectiveness were tested in 3 trials including over 500 participants. Those participants taking Belsomra reported falling asleep faster and spending more time asleep than those taking placebo. Belsomra was not compared to other sleep medications. 

Next-day drowsiness was the most commonly reported side effect. The drug’s manufacturer also warned of impairment of next-day driving performance in patients taking 20 mg of Belsomra.

FDA. FDA approves new type of sleep drug, Belsomra [press release]. August 13, 2014. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409950.htm. Accessed August 19, 2014

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Plegridy: Multiple Sclerosis

The FDA has approved Plegridy, a pegylated beta interferon, for treatment of patients with relapsing forms of multiple sclerosis (MS).

The drug is available in both prefilled syringe and autoinjector, and is to be taken once every 2 weeks. 

Researchers tested the efficacy of Plegridy in the ADVANCE study, involving more than 1500 MS patients. In the 2-year, phase 3 trial, Plegridy reduced annualized relapse rate by 36% over placebo. It also reduced new gadolinium-enhancing lesions by 86% and new T2-hyperintense lesions by 67%.

The most common side effects reported were injection-site reaction, fever, flu-like illness, headache, chills, weakness, and muscle pain.  

BusinessWire. Biogen Idec’s PLEGRIDY (Peginterferon Beta-1a) approved in the US for the treatment of multiple sclerosis [press release]. August 15, 2014. www.businesswire.com/news/home/20140815005610/en/Biogen-Idec%E2%80%99s-PLEGRIDY%E2%84%A2-Peginterferon-Beta-1a-Approved-Treatment#.U_NNtEjCtig. Accessed August 19, 2014.