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The frontline indication for afatinib (Gilotrif) has been expanded by the FDA to include&nbsp;the treatment of patients with metastatic non&ndash;small cell lung cancer whose tumors harbor uncommon <em>EGFR</em> alterations in L861Q, G719X, and/or S768I.

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.

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).

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.