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In the pipeline
Drugs in Development and New Indications
Curette Uses Coil Design for Cervical Sampling
FemSuite’s new endocervical curette (FemECC) for use in cervical biopsy
is pending approval from the US Food and Drug Administration (FDA). The new disposable
curette allows for a more effective extrusion of superior tissue samples, compared
to traditional curettes. The device features a screw-like design that results
in continuous, coherent endocervical tissue samples.
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A Different Drug
for Women
After a meeting with the FDA, Cell Therapeutics, Inc, announced plans to file
a new drug application for paclitaxel poliglumex (Xyotax), for women with non—small-cell
lung cancer. Preclinical and clinical studies support that metabolism of the
drug by lung cancer cells may be greater and more efficacious in women because
it is influenced by estrogen. This novel treatment would address an unmet medical
need while exploring the potential of gender-specific cancer treatments.
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Putting Tumors on Ice
Endocare, Inc, unveiled its cryoablation probe (V-Probe) at the recent Annual
Meeting of the American Urological Association. The new device, in conjunction
with planning software, allows physicians to more precisely configure isotherms
to destroy tumors and glands of variable shapes and sizes, as well as conform
to individual patient anatomies and needs. This adaptable device offers an
individually tailored procedure with greater accuracy and fewer complications.
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Mitigating Mammary Metastasis
After a randomized, controlled, multicentered phase 3 study, Genentech, Inc,
submitted an application to the FDA for the approval of bevacizumab (Avastin)
as an adjuvant to paclitaxel chemotherapy for the treatment of locally recurrent
or metastatic breast cancer. Trial participants receiving the bevacizumab adjuvant
experienced a 52% reduction in disease progression or death without significantly
greater toxicity, compared to patients receiving paclitaxel alone. The median
progression-free survival rate in patients receiving bevacizumab was more than
1 year, in comparison to a median 6-month survival rate in patients receiving
paclitaxel alone. Bevacizumab is currently approved for the treatment of colorectal
cancer.
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Rest Assured,
Sleep Is on Its Way
Neurocrine Biosciences, Inc, received an approvable letter from the FDA for indiplon
5-mg and 10-mg capsules for the treatment of insomnia. Clinical trials demonstrated
that the drug helped patients fall asleep faster and stay asleep longer, with
decreased frequency of waking during the night and overall increased quality
of sleep. Indiplon 15-mg extended-release tablets are not approvable at this
time.
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