New Products: FDA approves combination regimen to treat advanced RCC

FDA approves combination regimen to treat advanced RCC

Woodcliff Lake, NJ-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 grants approval to treatment for advanced RCC

South San Francisco-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.

Image courtesy of Genentech

FDA grants accelerated approval of treatment for advanced urothelial cancer

San Francisco-Genentech has announced that the FDA has granted accelerated approval to atezolizumab [TECENTRIQ] for the treatment of people with locally advanced or metastatic urothelial carcinoma  who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. The indication for atezolizumab is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, Genentech said. The approval is based on the phase II IMvigor 210 study. Potential serious side effects associated with the use of atezolizumab include pneumonitis, hepatitis, colitis, hormone gland problems, nervous system problems, and eye problems. severe infections, and severe infusion reactions. 

For more information, visit  http://www.gene.com. 

Test helps identify candidates for new bladder cancer agent

Burlington, NC-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 approves smart mobile-connected ultrasound device for urology

Kirkland, WA-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. 

Image courtesy of TOLMAR Pharmaceuticals

FDA approves label update for LHRH treatment for prostate cancer

Lincolnshire, IL-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.

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