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The FDA has accepted a Biologics License Application for MYL-1402O, a proposed biosimilar to bevacizumab, according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

Most patients with metastatic renal cell carcinoma whose disease progresses after immunotherapy given either alone or in combination with other agents receive subsequent treatment with VEGF tyrosine kinase inhibitors or mTOR inhibitors. When administered post-immunotherapy, cabozantinib is associated with superior median progression free survival, according to retrospective data from a real-world study of patients treated at 16 Italian referral centers.

Stereotactic body radiotherapy combined with nivolumab was associated with “high” disease control and overall survival rates in a phase II study of pretreated patients with metastatic renal cell carcinoma, according to lead investigator Cristina Masini, MD, who presented the data at the 2020 Genitourinary Cancers Symposium.

Bradley McGregor, MD, clinical director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, senior physician, instructor in medicine, Harvard Medical School, discusses the goals of the phase III CheckMate-9ER trial, which is evaluating cabozantinib combined with nivolumab in previously untreated patients with advanced or metastatic renal cell carcinoma (RCC).

The combination of ilixadencel plus sunitinib has demonstrated favorable survival compared with sunitinib alone in patients with newly diagnosed metastatic synchronous renal cell carcinoma, Immunicum AB announced in a press release. The research update presented at the 2020 American Society of Clinical Oncology-Society for Immunotherapy of Cancer Clinical Immuno-Oncology Symposium showed a survival curve separation in the phase II MERECA trial that gives promising signals for the future.

Integrating a geriatric assessment into the care of older adults who are receiving cancer treatment in communi­ty oncology practices improves patient and caregiver satisfaction and encourages commu­nication about aging-related concerns, accord­ing to results of a clinical trial that enrolled 541 patients with advanced cancer.