FDA Approves Enfortumab Vedotin for Treatment of Locally Advanced or Metastatic Urothelial Cancer
July 9th 2021“For the first time, physicians can treat advanced urothelial cancer following treatment with a platinum-containing therapy and immunotherapy using an FDA-approved therapy that has demonstrated an OS benefit compared with chemotherapy.”
Telaglenastat Plus Cabozantinib Fails to Improve PFS in Metastatic RCC, But Still Holds Promise
July 6th 2021The results of the phase 2 CANTATA trial indicate that the combination of telaglenastat/cabozantinib does not significantly improve PFS, however, telaglenastat might still prove effective in certain populations.
Cabozantinib Associated With Higher Rates of Certain AEs in Advanced Kidney Cancer
June 11th 2021While cabozantinib exposure was not a predictor of progression-free survival, it was related to high rate of palmar-plantar plantar erythrodysesthesia and diarrhea in patients with advanced renal cell carcinoma who are given frontline cabozantinib plus nivolumab.
Bone-Protecting Agents Reduce Fracture Risk During Prostate Cancer Treatment
June 9th 2021Men with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer who are being treated with radium-223 (Xofigo) plus enzalutamide (Xtandi) can reduce their risk of fractures with the use of bone-protecting agents.
AI-Based Focal Therapy System Get a Breakthrough Device Designation for Prostate Cancer Treatment
May 12th 2021The FDA has granted a breakthrough device designation to the Avenda Health Focal Therapy System, a male “lumpectomy” product under development to treat patients with prostate cancer in office while preserving quality of life.
Drug Combo Improves PFS in mCRPC
May 3rd 2021The novel oral TKI masitinib in combination with docetaxel and prednisone resulted in improved progression-free survival compared with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer, meeting the predefined primary end point of the phase 2b/3 AB12003 trial.
Adjuvant Nivolumab Granted Priority Review for Muscle-Invasive Urothelial Carcinoma
May 2nd 2021The FDA has granted a priority review designation to a supplemental biologics license application for nivolumab for use as an adjuvant treatment in patients with surgically resected, high-risk, muscle-invasive urothelial carcinoma.
FDA Approves Sacituzumab Govitecan for Previously Treated Metastatic Urothelial Cancer
April 13th 2021The FDA granted an accelerated approval to sacituzumab govitecan (Trodelvy) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously had a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
Immunotherapy Enters Liver Cancer Treatment
March 30th 2021Although the combination of atezolizumab and bevacizumab has become the standard frontline treatment for patients with advanced hepatocellular carcinoma, whether immunotherapy could play a role in earlier lines of treatment remains the subject of ongoing research.
Belzutifan Granted Priority Review for VHL Disease–Associated RCC
March 17th 2021The FDA has granted priority review to the new drug application for the HIF-2α inhibitor belzutifan for the potential treatment of patients with von Hippel-Lindau–associated renal cell carcinoma that does not require immediate surgery.
Vicineum Granted Priority Review for High-Risk, BCG-Unresponsive Bladder Cancer
February 18th 2021The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.