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The FDA granted approval to countless treatments across cancer types throughout 2019 until the end of the year, with a final approval on December 31<sup>st </sup>for the first BRCA targeted therapy in pancreatic cancer. Following the excitement for a new year of further advances, Targeted Oncology followers on Twitter shared their thoughts on some of the most impactful FDA approvals in 2019.

In an interview with Targeted Oncology, Thomas Yau, MD, discussed the findings from the phase III CheckMate trial evaluating nivolumab in patients with advanced hepatocellular carcinoma compared with standard-of-care sorafenib. He highlighted the next steps for the trial following these data, which were presented at the 2019 European Society of Medical Oncology Congress.

María Varela, MD, PhD, discusses the findings from a real-life analysis to confirm the benefit of regorafenib as treatment of patients with hepatocellular carcinoma who have progressed on prior sorafenib. Regorafenib was approved by the FDA for second-line treatment in this patient population based on data from the phase III RESORCE trial.

In November 2019, the FDA approved a number of treatments, including acalabrutinib for the treatment of chronic lymphocytic leukemia and small lymphocytic leukemia, as well as zanubrutinib for the treatment of mantle cell lymphoma. A biosimilar for pegfilgrastim was also approved under indications.
















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–National Cancer Institute–European Organization for Research and Treatment of Cancer International Conference on Molecular Targets and Cancer Therapeutics.

What is the ideal first-line<strong> </strong>therapy for nonresectable, non– transplant eligible, liver-only hepatocellular carcinoma? In a debate at the 2019 Gastrointestinal Oncology Conference, Mark Yarchoan, MD, had the unenviable task of convincing the audience that systemic therapy was the way to go.

The frontline combination of atezolizumab and bevacizumab statistically and clinically improved progression-free survival and overall survival compared with sorafenib in patients with hepatocellular carcinoma in the phase III IMbrave150 study, according to a press release from Roche.

Mark Yarchoan, MD, explains his method for sequencing available treatment options for patients with hepatocellular carcinoma.<br />

In an interview with Targeted Oncology, Mark Yarchoan, MD, discussed the treatment options available for patients with liver-only HCC who are not eligible for surgery or transplant. He also highlighted the different treatment options that are under investigation now for patients with HCC in the first- and second-line settings.

A supplemental Biologics License Application for the combination of nivolumab and ipilimumab for the treatment of patients with advanced hepatocellular carcinoma previously treated with sorafenib has been accepted by the FDA and given Priority Review status. The supplemental Biologics License Applicationwas given a Prescription Drug User Fee Act goal date of March 10, 2020, according to a press release from Bristol-Myers Squibb.<br />

















































