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The FDA has accepted and granted a priority review to a supplemental Biologics License Application for pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high who have progressed following prior treatment and who have no satisfactory alternative treatment options.

GEN-1 immunotherapy demonstrated dose-dependent efficacy results in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer when treated in combination with the standard of care, according to results from the OVATION 2 study. Based on positive data in the phase I portion, the study is moving on to phase II with enrollment expected to begin in the second half of the year.

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.

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

Myriad Genetics, Inc, has submitted a supplementary premarket approval application to the FDA for the myChoice CDx test for use in predicting outcomes for women with frontline platinum-responsive advanced ovarian cancer who are treated with niraparib, a PARP inhibitor, according to a press release from Myriad Genetics, Inc., the manufacturer of the test.

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.

The present and future benefits of telehealth in oncology can be observed through Tahoe For­est Cancer Center and its affiliation with the UC Davis Cancer Center, use of other remote clinics, and participation in virtual tumor boards. Even though there are roadblocks to telehealth reaching more locations and more patients, the potential benefit warrants the time needed to get over those hurdles.

Preliminary data showed that the combination of sitravatinib and tislelizumab is well tolerated and may promote antitumor activity when administered to patients with platinum-resistant ovarian cancer, according to a press release from BieGene, Ltd, which reported data from a phase Ib study at the 2019 European Society of Oncology Immuno-Oncology Congress in Geneva, Switzerland.<br /> &nbsp;

In patients whose solid<strong> </strong>tumors harbor a mutation in <em>KRAS </em>G12C, therapy with MRTX849 has produced promising responses and acceptable toxicity across 3 tumors types, according to data presented at the 2019 American Association for Cancer Research&ndash;National Cancer Institute&ndash;European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.