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The FDA closed out the year by approving several new agents last month, including bevacizumab for glioblastoma, cabozantinib for renal cell carcinoma, nivolumab for melanoma, bosutinib for chronic myeloid leukemia, and pertuzumab for HER2+ breast cancer. In addition, several agents were granted a priority review designation. Here is a look back at all the FDA activity that took place in December.

Hyperprogressive disease (HPD) after immunotherapy treatment may not be as rare of a phenomenon as previously thought. A recent multicenter, retrospective analysis of 242 patients with advanced non&ndash;small cell lung cancer&nbsp;(NSCLC) found that 16% of patients developed hyperprogression during anti&ndash;PD-1/ PD-L1 treatment.<sup>1</sup> The study, which was presented at the 2017 ESMO Annual Congress, is one of the latest to highlight the risk of hyperprogression.

A supplemental new drug application (sNDA) for osimertinib (Tagrisso) has been granted a priority review by the FDA&nbsp;as a first-line treatment for patients with non&ndash;small cell lung cancer (NSCLC) whose tumors harbor <em>EGFR</em> mutations (exon 19 deletions or exon 21 [L858R] substitution mutations).

One of the most important effects of the positive findings for entrectinib in patients with ROS1 fusion&ndash;positive non&ndash;small cell lung cancer&nbsp;(NSCLC) is the potential impact on patients with central nervous system (CNS) metastases, according to Robert C. Doebele, MD, PhD.

According to findings presented at the 2017 World Conference on Lung Cancer, the&nbsp;potent and selective inhibitor of ROS1 and TRKentrectinib induced an objective response rate of 68.8% by blinded independent central review, which included 2 complete responses (6.3%), for patients with <em>ROS1</em> fusion-positive advanced non&ndash;small cell lung cancer.

AstraZeneca has submitted a&nbsp;supplemental new drug application to Japan&#39;s&nbsp;Pharmaceuticals and Medical Devices Agency for the use of the&nbsp;third-generation, irreversible EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) in the frontline treatment of patients with&nbsp;inoperable or recurrent <em>EGFR</em>-positive non&ndash;small cell lung cancer.

After granting a priority review to durvalumab (Imfinzi) in October for the treatment of patients&nbsp;with stage III, unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation, the FDA is now reviewing results from the phase III PACIFIC trial, which have now&nbsp;been published in the print edition of the New England Journal Medicine.

Although great advances have been made in the treatment of advanced, metastatic, and nonresectable, nonsquamous, non&ndash;small cell lung cancer (NSCLC), prognosis remains relatively poor, and recurrence is common. Howard Jack West, MD, medical director of the Thoracic Oncology Program at Swedish Cancer Institute, Seattle, Washington, explained in an abstract that &ldquo;platinum-based chemotherapy is the current standard of care for patients with newly diagnosed advanced nonsquamous NSCLC.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for approximately 80% to 85% of lung cancer cases, whereas small cell lung cancer (SCLC) comprises approximately 10% to 15% of lung cancer cases.

Nonsquamous non&#8210;small cell lung cancer (NSCLC) is a heterogeneous disease with multiple treatment options dependent upon staging, presence of metastasis, and patient factors&mdash;including presence of comorbidities&mdash;among other considerations. As such, current treatment options include surgical resection, chemotherapy, radiation, immunotherapy, and targeted therapy.

In a presentation at the&nbsp;35th annual CFS, Edward S. Kim, MD, discussed the &quot;renaissance&quot; in the&nbsp;non&ndash;small cell lung cancer landscape that has come with the rapid evolution of targeted treatment for patients with&nbsp;<em>EGFR</em>-mutation&ndash;positive disease.

David R. Gandara, MD, director, Thoracic Oncology Program, professor, senior advisor to director, UC Davis Comprehensive Cancer Center, UC Davis Health System, discusses results of the ALEX clinical trial, which compared alectinib (Alecensa) versus crizotinib (Xalkori) in patients with ALK+&nbsp;non&ndash;small cell lung cancer (NSCLC).