New Products: Avelumab/axitinib combo is first-line treatment for advanced RCC


Also learn about patient-focused bladder cancer guidelines, a new vaginal ring pessary for pelvic organ prolapse, and more.

Merck and Pfizer recently announced FDA approval of avelumab (BAVENCIO) in combination with axitinib (INLYTA) for the first-line treatment of patients with advanced renal cell carcinoma. The companies say this is the first such approval for an anti-PD-L1 therapy as part of a combination regimen for patients with advanced RCC. The approval was based on positive results from the phase III JAVELIN Renal 101 study (NCT02684006), in which the combination significantly improved median progression-free survival compared with sunitinib (Sutent) by more than 5 months in the intent-to-treat patient population (HR: 0.69 [95% CI: 0.56-0.84]; 2-sided p-value=.0002; median progression-free survival for BAVENCIO/INLYTA combination: 13.8 months [95% CI: 11.1-NE]; sunitinib: 8.4 months [95% CI: 6.9-11.1]). The intent-to-treat population included patients regardless of PD-L1 expression and across International Metastatic Renal Cell Carcinoma Database prognostic risk groups.

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Next: NCCN publishes patient-focused bladder cancer guidelines

NCCN publishes patient-focused bladder cancer guidelines

The National Comprehensive Cancer Network announced the publication of “NCCN Guidelines for Patients: Bladder Cancer.” Created with funding through the NCCN Foundation, the guidelines have been endorsed by the Bladder Cancer Advocacy Network, the American Bladder Cancer Society, and the Urology Care Foundation. The document is based on the evidence and expert consensus from the NCCN Guidelines. The recommendations are determined by a multidisciplinary panel of bladder cancer experts from across the 28 NCCN member institutions. Treatment options are presented in user-friendly terms in the patient guidelines, complete with glossary, illustrations, suggested questions for the provider, and a space to take notes.


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Next: New vaginal ring pessary for pelvic organ prolapse available

New vaginal ring pessary for pelvic organ prolapse available

The FDA has granted approval for ConTIPI Medical Ltd. to market its new product, ProVate, which is designed to treat pelvic organ prolapse in women. The ProVate Device is a vaginal ring pessary that comes ready for use in small dimensions (compacted mode) within a disposable applicator. The applicator allows for a smooth insertion into the vagina. When the plunger of the applicator is depressed, the device becomes fully deployed, restoring its predefined size (deployed mode), and separates from the applicator, which is then removed from the vagina for disposal. Once deployed within the vagina, as with other ring pessaries, the ProVate support distends lateral vaginal walls aside, mechanically prevents cervical/vault descent, and with its central piece, blocks further descent of the anterior/posterior walls within the hollow of the ring, ConTIPI Medical says. The device is provided in six sizes.


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Next: PatientPoint, Us TOO to partner on prostate Ca patient information

PatientPoint, Us TOO to partner on prostate Ca patient information

PatientPoint and prostate cancer nonprofit Us TOO International have announced a new partnership to bring a custom blend of actionable prostate cancer education, treatment, and support information to urology exam rooms nationwide. The partnership pairs PatientPoint education with information about Us TOO resources via a newly updated PatientPoint prostate cancer brochure designed exclusively for the exam room. The PatientPoint prostate cancer brochure in which Us TOO resources are featured addresses all phases of the prostate cancer journey, including diagnosis, treatment, side effects, coping, and ongoing care.


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Next: Melanocortin agonist treats hypoactive sexual desire disorder

Melanocortin agonist treats hypoactive sexual desire disorder

The FDA has approved bremelanotide injection (Vyleesi), a melanocortin receptor agonist, to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. The Vyleesi autoinjector is the first treatment for this patient population that can be self-administered as needed in anticipation of sexual activity, according to manufacturer AMAG Pharmaceuticals, Inc. The FDA approval is based on data from approximately 1,200 women in two pivotal, double-blind placebo controlled phase III trials (RECONNECT). In both clinical trials, bremelanotide injection met the pre-specified co-primary efficacy endpoints of improvement in desire and reductions in distress as measured by validated patient-reported outcome instruments. Upon completion of the trial, women had the option to continue in a voluntary open-label safety extension study for an additional 12 months. Nearly 80% of patients who completed the phase III trials elected to remain in the open-label portion of the study.


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Next: New combination antibacterial indicated for complicated UTIsNew combination antibacterial indicated for complicated UTIs

The FDA has approved Merck’s imipenem, cilastatin, and relebactam for injection, 1.25 grams (RECARBRIO), a new combination antibacterial. The treatment is indicated in patients 18 years of age and older who have limited or no alternative treatment options for the treatment of complicated urinary tract infections, including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Merck said it anticipates making the treatment available later this year.


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FDA approves bevacizumab biosimilar; mRCC among indications

The FDA has approved bevacizumab-bvzr (ZIRABEV), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer, including metastatic renal cell carcinoma. The approval was based on review of a comprehensive data package that demonstrated biosimilarity of bevacizumab-bvzr to the reference product.


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