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October 2018

An overview of the regulatory activities of the Office of Oncology Drug Products and the Office of Hematology and Oncology Drug Products from 2008 to 2016 suggests that the FDA has made consistent use of regulatory mechanisms to expedite approvals during that period. Investigators from the Office of Biostatistics, Center for Drug Evaluation and Research completed an analysis to determine if changes in the laws, regulations, and the agency that occurred after 2007 had an effect on regulatory approvals.

With 2 CAR T-cell therapies now approved and more moving quickly through early-phase clinical trials, 4 healthcare experts reflected on the evolving field of CAR T-cell therapy, their understanding of its current and future applicability for patients, the process for administration and the challenges and obstacles that remain unaddressed during an Association of Community Cancer Centers interactive panel.<br /> &nbsp;

In results presented at the European Society for Medical&nbsp;Oncology&rsquo;s 2018 Molecular Analysis for Personalised Therapy Congress, Marlene Kok, MD, PhD, said results from the phase II TONIC study showed that induction therapy with doxorubicin turned &ldquo;cold&rdquo; tumor cells &ldquo;hot,&rdquo; resulting in an objective response rate of 20% following treatment with nivolumab.

The number of women who develop gestational trophoblastic neoplasia during pregnancy is limited, yet physicians believed that a greater understanding of how to manage this disease was necessary. New guidelines were recently issued by the National Comprehensive Cancer Network to help gynecologic oncologists understand how to treat this rare gestational cancer. Generally, the use of single-agent chemotherapy for most patients with low-risk disease is recommended, with the guidelines reserving surgery and combination chemotherapy for patients at high risk of GTN.<sup>1</sup>

Combining the PD-1 checkpoint inhibitor nivolumab with the CTLA-4 checkpoint inhibitor ipilimumab led to superior survival rates compared to treatment with nivolumab alone in patients with persistent or recurrent ovarian cancer, according to findings from the phase II NRG-GY003 trial.

Until recently, few systemic therapies had been approved for the treatment of patients with liver cancer, as few agents could demonstrate significant benefit over placebo. Sorafenib was the first systemic therapy that extended median overall survival over placebo by nearly 3 months,<sup>1</sup> and, in December 2007, it became the first systemic therapy approved by the FDA for patients with unresectable hepatocellular carcinoma.