Schizophrenia

FDA Roundup: New Options for Schizophrenia, Lung Cancer, Pathogen Detection

Aristada – Schizophrenia

The FDA has approved Aristada (aripiprazole lauroxil) extended release injection for the treatment of adults with schizophrenia.1

Aristada is to be administered every 4-6 weeks by a health care professional via injection into the arm or buttocks.
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The safety and efficacy of Aristada was evaluated in a 12-week clinical trial of 622 participants in which Aristada was found to maintain treatment effect in patients with acute schizophrenia stabilized with oral aripiprazole.

The drug carries a boxed warning of increased risk of death associated with off-label use. The most common side effect is akathisia.

Keytruda – Non-Small Cell Lung Cancer

The FDA has approved Keytruda (pembrolizumab) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with tumors that express the protein PD-L1, and for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, used for detecting such tumors.2

Keytruda was previously approved for the treatment of patients with advanced melanoma following treatment with ipilimumab.

The efficacy of the drug were evaluated in a study of 61 patients enrolled in a larger, multi-part study. Participants were given 10 mg/kg of Keytruda every 2-3 weeks. In patients treated with the drug, tumors shrank 41% compared with those not treated. The effects lasted between 2.1 and 9.1 months.

The safety of the drug was evaluated in a study of 550 patients with advanced NSCLC. The most common side effects were fatigue, decreased appetite, impaired breathing, and cough. 

FilmArray Meningitis/Encephalitis Panel

The FDA has allowed the marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for the detection of multiple pathogens that can cause nervous system infections, the FilmArray Meningitis/Encephalitis Panel.3

The test uses CSF specimens from patients with possible infection and is intended for use in conjunction with other clinical findings. It is designed to simultaneously test for 14 pathogens and provides results in about an hour using only a small amount of CSF.

The 14 pathogens are Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae and Cryptococcus neoformans/gattii. Cytomegalovirus, Enterovirus, Herpes simplex virus 1, Herpes simplex virus 2, Human herpesvirus 6, Human parechovirus, and Varicella zoster virus.

In a review of 1560 patients with suspected infection, a review of 150 CSF samples previously determined to contain infection, and a a study of 425 CSF samples artificially prepared with infection, the test results demonstrated high agreement with other methods and expected results.

—Michael Potts

References:

  1. FDA. FDA approves new injectable drug to treat schizophrenia [press release]. October 6, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465801.htm.
  2. FDA. FDA approves Keytruda for advanced non-small cell lung cancer. [press release]. October 2, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm.
  3. FDA. FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid. [press release]. October 8, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm466360.htm.