Other products in this round-up include treatments for advanced renal cell carcinoma, metastatic urothelial cancer, and more.
Trocar allows one-handed laparoscope/hand instrument control
The Fujifilm InterLock Trocar is a novel tandem motion visualization device that allows a surgeon to control both a laparoscope and a hand instrument at the same time and with one hand. The device is designed to provide surgical access through a single incision for both a 5-mm hand instrument and the Fujifilm Ultra-Slim “Chip on the Tip” HD Video Laparoscope. The technology allows the surgeon full control of the scope throughout the procedure by directly controlling the hand instrument. Tandem motion of the hand instrument and the Fujifilm scope is achieved through a coupling mechanism within the InterLock Trocar. Additional features include an integrated lens-cleaning function, which allows the lens to be cleaned and restores image quality without removing the scope from the trocar-saving time and reducing the need for repositioning, according to Fujifilm New Development U.S.A., Inc. The device has received 510k clearance from the FDA and will be commercially available in the United States later this year.
For more information, visit www.fujifilmmis.com.
FDA approves first-line treatment for advanced renal cell carcinoma
The FDA has approved pembrolizumab (KEYTRUDA), a PD-1 inhibitor, in combination with xitinib (Inlyta), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The approval is based on findings from the pivotal phase III KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) for pembrolizumab in combination with axitinib compared to sunitinib (Sutent). For the main efficacy outcome measures of OS and PFS, the pembrolizumab-axitinib combination reduced the risk of death by 47% compared to sunitinib (HR=0.53 [95% CI: 0.38-0.74]; p<.0001); for PFS, the pembrolizumab-axitinib combination showed a reduction in the risk of progression of disease or death of 31% compared to sunitinib (HR=0.69 [95% CI: 0.57-0.84]; p=.0001). The ORR was 59% for patients who received the pembrolizumab-axitinib combination (95% CI: 54-64) and 36% for those who received sunitinib (95% CI: 31-40) (p<.0001). This is the first indication for pembrolizumab in advanced RCC and the first anti-PD-1 therapy FDA-approved as part of a combination regimen that significantly improved OS, PFS, and ORR versus sunitinib in patients with advanced RCC, according to Merck.
For more information, visit www.merck.com.
Accelerated approval granted for metastatic urothelial Ca agent
The Janssen Pharmaceutical Cos. of Johnson & Johnson announced that erdafitinib (BALVERSA) received accelerated approval from the FDA for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations and who have progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Erdafitinib is the first FGFR kinase inhibitor approved by the FDA, according to Janssen. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The FDA simultaneously approved a companion diagnostic for use with erdafitinib, the QIAGEN therascreen FGFR RGQ reverse-transcription-polymerase chain reaction kit, which is the first polymerase chain reaction-based companion diagnostic approved to detect FGFR alterations.
For more information, visit www.jnj.com.
Newly approved oral capsules are for TRT in certain adult men
The FDA has approved testosterone undecanoate capsules for oral use (CIII) (JATENZO) for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). JATENZO is a first-in-class proprietary softgel oral formulation and the first oral testosterone medicine approved in more than 60 years, according to Clarus Therapeutics. FDA approval is based on phase III inTUne clinical trial data, which showed 87% of hypogonadal men treated with JATENZO achieved a daily average testosterone level in the normal range, with an adverse event profile generally consistent with other testosterone replacement therapies.
For more information, visit www.clarustherapeutics.com.
New version of PI-RADS prostate imaging system released
The PI-RADS Steering Committee-a collaboration of the American College of Radiology, European Society of Urogenital Radiology, and AdMeTech Foundation-has released an update, Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1). This version introduces several modifications while maintaining the original framework of assigning scores to individual imaging sequences and using these scores to derive, on a lesion-by-lesion basis, an overall likelihood that an abnormal area in the prostate represents clinically significant prostate cancer.
For more information, visit www.acr.org.
Delivery model works with physicians to help treat pelvic floor disorders
Consortia Health has created an integrated delivery model working with physicians to provide diagnosis, treatment, and educational support to address pelvic floor disorders, including urinary incontinence, pelvic pain, and sexual health. Consortia Health says its rehabilitation therapy has proven effective in minimizing incontinence symptoms in up to 95% of patients. The treatment consists of weekly 30-minutes sessions using FDA-approved neuromodulation technology designed to retrain the pelvic floor muscles.
For more information, visit www.consortiahealth.com.