Urology FDA approvals of 2016

Noninvasive prostate MRI system improves lesion conspicuity

Siemens Healthcare received FDA clearance for its noninvasive SEEit prostate magnetic resonance imaging (MRI) solution. SEEit uses high-channel surface coils, providing a noninvasive image technique that improves lesion conspicuity in diffusion-weighted imaging with Siemens’ RESOLVE technology, the company says. It offers improved patient set-up and accelerated scans to help optimize process efficiency. Powered by syngo MR E11 software architecture, SEEit gives users high-performance MAGNETOM Aera 1.5 Tesla and MAGNETOM Skyra 3T MRI systems that can perform a routine prostate exam in just 10 minutes without using an endorectal coil. Use of Direct RF and high-density coil technology Tim 4G and RESOLVE technology delivers the essential signal-to-noise ratio and resolution that enable users to perform prostate MRI using only the company’s new Body 30/60 surface coil, according to Siemens.

For more information, visit www.usa.siemens.com/prostatemri.

Targeted prostate biopsy device receives FDA clearance

Focal Healthcare Inc. received 510(k) FDA clearance for its targeted prostate biopsy device, Fusion Bx. It is designed to take targeted biopsies directly from suspicious cancer regions within the prostate using MRI-ultrasound fusion technology. According to the company, fusion biopsy has been shown to detect high-grade cancer in 30% more men compared to traditional systematic biopsy. By accurately determining the location and extent of the cancer, this procedure also allows clinicians to confidently monitor cancer progression over time and prescribe the appropriate course of treatment to patients with varying grades of cancer. The 510(k) clearance includes the use of Fusion Bx for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2-D and 3-D image visualization, including review, manipulation, and analysis tools.

For more information, visit http://focalhealthcare.com/.

FDA approves label update for LHRH treatment for prostate Ca

TOLMAR Pharmaceuticals has announced that it received FDA approval for a label update for leuprolide acetate for injectable suspension (Eligard), a luteinizing hormone-releasing hormone (LHRH) agonist. Prior to mixing, the drug may be stored for up 8 weeks at room temperature (59–86° F) following removal from refrigeration, according to the FDA. Eligard, indicated for the palliative treatment of advanced prostate cancer, uses a controlled-release delivery system known as ATRIGEL. It is available in 1-, 3-, 4-, and 6-months doses.

For more information, visit www.tolmar.com.

FDA approves mobile-connected ultrasound device for urology

Signostics has received FDA 510(k) clearance for Uscan, a smart mobile-connected ultrasound visualization device designed for urologic care. Uscan uses computer vision algorithms to actively recognize the 3-D contours of the bladder. It is able to capture up to 256 3-D bladder slices and can provide real-time ultrasound imaging of the kidneys, pelvic floor, prostate, gallbladder, bladder stones, and catheter emplacement. Uscan also offers integrated middleware and has capabilities beyond urology. It is compatible with Android operating systems and has built-in Wi-Fi and Bluetooth connectivity for interoperability with electronic medical record systems.

For more information, visit www.signosticsmedical.com.

Test helps identify candidates for new bladder cancer agent

Laboratory Corp. of America Holding (LabCorp) has made available VENTANA PD-L1 (SP142) Assay as a complementary diagnostic test in the treatment of urothelial cancer. Designed to be used in conjunction with atezolizumab (TECENTRIQ), which was recently FDA approved for the treatment of certain individuals with locally advanced or metastatic urothelial carcinoma, VENTANA PD-L1 Assay will help identify patients who may benefit from atezolizumab treatment. The test was developed by Roche Diagnostics. It can identify the PD-L1 protein on tumor infiltrating immune cells and will also provide physicians with an immune cell scoring algorithm. VENTANA PD-L1 Assay was approved by the FDA in May 2016.

For more information, visit www.labcorp.com.

FDA grants approval to treatment for advanced RCC

Exelixis has announced that the FDA approved cabozantinib (Cabometyx), which targets multiple tyrosine kinases, for the treatment of patients with advanced renal cell carcinoma who have received prior angiogenic therapy. In a phase III trial of patients with advanced RCC, the therapy demonstrated clinically meaningful improvements in all three key efficacy parameters-overall survival, progression-free survival, and objective response rate. In comparison with treatments using everolimus, cabozantinib demonstrated a 42% reduction in the rate of disease progression or death. Median progression-free survival for cabozantinib was 7.4 months compared to 3.8 months for everolimus, and median overall survival was 21.4 months for cabozantinib-treated patients versus 16.5 months for those treated with everolimus. The most common side effects associated with cabozantinib include diarrhea, fatigue, nausea, decreased appetite, hand-foot syndrome, high blood pressure, vomiting, weight loss, and constipation.

For more information, visit www.exelixis.com.

FDA approves combination regimen to treat advanced RCC

Eisai Inc. has announced that it has received FDA approval for lenvatinib (Lenvima), a multiple receptor tyrosine kinase inhibitor, in combination with everolimus (Afinitor) for the treatment of individuals with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. During the registration study, the once-daily combination of lenvatinib, 18 mg, and everolimus, 5 mg, demonstrated an improvement in progression-free survival, objective response rate, and overall survival when compared with treatments using only everolimus. Patients using the combination therapy experienced a 63% reduction in the risk of disease progression or death compared with everolimus alone. The combination regimen also saw patients experience a 10.1-month increase in average overall survival versus everolimus monotherapy. The most common adverse reactions in study patients were hypertension, cardiac dysfunction, arterial thromboembolic events, hepatotoxicity, proteinuria, diarrhea, renal failure and impairment, gastrointestinal perforation and fistula formation, and QT interval prolongation.

For more information, visit www.eisai.com/US.

FDA approves RCC treatment that targets immune system

Bristol-Myers Squibb received FDA approval for nivolumab (Opdivo) injection, for intravenous use, for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that works by targeting the immune system through the PD-1 immune checkpoint pathway. It is the first PD-1 inhibitor to deliver significant overall survival in patients with advanced RCC who have received prior anti-angiogenic therapy, according to Bristol-Myers Squibb. The approval was based on data from a study of patients with advanced RCC who were randomized to receive either nivolumab or everolimus (Afinitor). Those treated with nivolumab lived an average of 25 months after treatment initiation versus 19.6 months in those treated with everolimus. The most common side effects associated with the use of nivolumab include weakness and lack of energy, cough, nausea, rash, dyspnea, and arthralgia.

For more information, visit www.bms.com.

Laser fiber safety device helps prevent intraoperative fires and injuries

Patient Pocket, LLC has launched the LaserDock, a single-use, disposable surgical laser fiber safety holder designed to house and protect laser fibers during laser surgery. “Regarding laser stone surgery, there are cases in which laser fiber safety is not addressed,” according to Steven Nakada, MD, of the Laser Safety Advisory Panel and the University of Wisconsin, Madison. The LaserDock has been cleared for marketing by the FDA under the 510(k) regulatory process. Used properly, it helps to prevent intraoperative fires and injuries due to accidental laser energy discharge, aiding surgeons and operating room personnel to better conform to FDA and Joint Commission standards. LaserDock can be used with holmium, GreenLight, and CO2 laser fibers.

For more information, visit www.patientpocket.com.

FDA approves sNDA to update labeling of CRPC drug

The FDA has approved a supplemental New Drug Application (sNDA) for enzalutamide (XTANDI) that will update the U.S. product labeling to include new clinical data about how the drug performed against bicalutamide, according to Astellas Pharma Inc. and Pfizer Inc. Based on the phase II TERRAIN Trial, data showed a nearly 40% improvement rate in radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (CRPC) who were treated with enzalutamide versus those treated with bicalutamide. The enzalutamide group data showed a median rPFS of 19.5 compared with 13.4 months in the bicalutamide group. The trial enrolled 375 chemotherapy-naïve patients with metastatic CRPC and was designed to evaluate patients on a randomized 1:1 basis. The study found the safety profile of enzalutamide to be consistent with previous trials.

For more information, visit www.xtandihcp.com.

Stent system receives FDA clearance

Brightwater Medical, Inc. has received FDA clearance for its ConvertX Nephroureteral Stent System to treat ureteral obstructions. Unlike traditional stent procedures, the ConvertX System does not require interventional radiologists to perform a second invasive procedure to exchange a nephrostomy catheter for an internal ureteral stent to circumvent the blockage. The system is converted from a catheter to a stent in a brief office procedure without the need for sedation or radiation and remains implanted in the patient like a standard internal ureteral stent. In addition to the FDA clearance, Brightwater also received a medical device manufacturing license from the California Department of Public Health for the ConvertX System.

For more information, visit www.brightwatermed.com.

What anti-PD-L1 immunotherapy approval means for urology

FDA approval of a new form of immunotherapy as well as a companion diagnostic test will have a significant impact on patients with the most common type of bladder cancer in the U.S., a leading urologic cancer expert says. Read more

Alcohol-free formula of docetaxel earns FDA approval

Teikoku Pharma USA has received FDA approval for a non-alcohol form of docetaxel injection, for the treatment of prostate cancer and other cancers. The new formula requires no prior dilution with a diluent and is ready to add to the infusion solution. It is available in three presentations: 20 mg/mL in single-dose vials, and 80 mg/4 mL or 160 mg/8 mL in multiple-dose vials. Teikoku said the novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment.

For more information, visit www.teikoku.co.jp/english/index_eng.html.

FDA approves vaginal insert to treat painful intercourse

The FDA has approved the once-daily vaginal insert, prasterone (Intrarosa), for the treatment of moderate to severe pain during sexual intercourse in women as a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The efficacy of the drug was established in two 12-week, placebo-controlled clinical trials of 406 healthy postmenopausal women. The women in the study ranged from 40 to 80 years old and all complained of moderate to severe pain during sexual intercourse as their most vexing symptom of VVA. The safety of the insert was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. Intrarosa is being marketed by Endoceutics, Inc.

For more information, visit www.endoceutics.com.

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