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On December 16, 2020, the FDA approved margetuximab-cmkb (Margenza), in combination with chemotherapy, for the treatment of adults with metastatic HER2-positive breast cancer. “As the only HER2-targeted agent to have shown a PFS improvement versus trastuzumab in a head-to-head phase 3 clinical trial, Margenza with chemotherapy represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” said Hope S. Rugo, MD.
On December 18, 2020, the FDA approved relugolix (Orgovyx), an oral GnRH receptor antagonist, for the treatment of men with advanced prostate cancer. This “approval marks the first oral drug in this class, and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider. This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic,” said Richard Pazdur, MD.
Targeted therapy has improved survival for patients with cancer across a broad spectrum of disease sites, but until recently, progress has been slow in the treatment of patients with cholangiocarcinoma (CCA).
Early studies with NUC-1031 alone or in combination with cisplatin showed higher-than-expected responses in patients, supporting that this mechanism is working, with no new or worsening side effects compared with gemcitabine.
In April 2020, the FDA granted accelerated approval to pemigatinib (Pemazyre), the first targeted therapy for cholangiocarcinoma (CCA). The FGFR inhibitor was approved for adults with CCA and FGFR2 fusion.
The recent FDA approval of the first FGFR inhibitor, pemigatinib (Pemazyre), and the positive results from the phase 3 study of the first IDH1 inhibitor, ivosidenib (Tibsovo), represent major breakthroughs in the treatment of patients with cholangiocarcinoma (CCA), a rare cancer associated with poor outcomes. However, the duration of response with these agents is still relatively short.
Patient-derived tumor organoids may have clinical application to predict drug responses in a personalized treatment setting; they have shown concordance with actionable genomic anchors and retrospective treatment outcomes.
New cytotoxic chemotherapy regimens and novel combinations are being evaluated in clinical trials in an effort to improve the outcomes of chemotherapy in the adjuvant and palliative settings in patients with biliary tract cancer, including cholangiocarcinoma (CCA), said Angela Lamarca, MD, PhD, MSc, Consultant, Medical Oncology, the Christie NHS Foundation Trust, Manchester, United Kingdom. She discussed the future of cytotoxic chemotherapy for this patient population at the 2020 Cholangiocarcinoma Summit.
Patient-reported outcomes from the phase 3 PRIMA clinical trial showed no detrimental effect of niraparib on quality-of-life measures compared with placebo in patients with newly diagnosed ovarian cancer.
Information on clinical aspects of COVID-19 and social and financial support services for the cancer community are abundant.
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