FDA News – June 2016

June 2016, Vol 7, No 5 - FDA Approvals, News & Updates


In This Article


Fluciclovine F18 Diagnostic Imaging Agent Approved to Detect Recurrent Prostate Cancer

On May 27, 2016, the FDA approved fluciclovine F18 (Axumin; Blue Earth Diagnostics) injection, a radioactive diagnostic imaging agent used to detect recurrent prostate cancer. Fluciclovine F18 injection is indicated for use with positron emission tomography (PET) imaging in patients with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels. “Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, MD, PhD, Director of the FDA’s Center for Drug Evaluation and Research Division of Medical Imaging Products. “Axumin is shown to provide another accurate imaging approach for these patients.” The FDA approval was based on 2 blinded studies evaluating the safety and efficacy of fluciclovine F18 injection. The first study compared 105 scans using fluciclovine F18 injection with histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in patients with suspected recurrence of prostate cancer. The second study compared the results from 96 scans using fluciclovine F18 injection with C11 choline scans, an approved PET scan imaging test, in men with a median PSA value of 1.44 ng/mL. In both studies, onsite radiologists and 3 independent radiologists read the scans, and their conclusions were generally consistent with one another. The most frequently reported adverse events were injection site pain, redness, and a metallic taste in the mouth. Because fluciclovine F18 is a radioactive drug, the FDA recommends appropriate safety measures to limit exposure to patients and providers during administration.

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Tecentriq for Metastatic Urothelial Bladder Cancer

On May 18, 2016, the FDA granted accelerated approval to atezolizu­mab (Tecentriq; Genentech) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or for those who have had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Atezolizumab received a breakthrough therapy designation in May 2014 for the treatment of metastatic bladder cancer that expresses PD ligand 1 (PD-L1) and was granted a priority review designation by the FDA in March 2016 for the treatment of locally advanced or metastatic urothelial carcinoma. The accelerated approval of atezolizumab was based on the results of the IMvigor 210 study, an open-label, multicenter, single-arm, phase 2 study of 310 patients with locally advanced or metastatic urothelial carcinoma who received 1200 mg of atezolizumab intravenously. The study’s primary end point was objective response rate (ORR), and the secondary end point was the duration of response. Atezolizumab conferred at least partial shrinkage of tumor in 9.4% of patients. The ORR in the study was 14.8%, and the median duration of response ranged from 2.1 months to 13.8 months. The ORRs were 9.5% in patients with PD-L1 expression of <5% and 26% in patients with PD-L1 expression ≥5%, suggesting that the level of PD-L1 expression may help identify the patients who are more likely to respond to therapy with atezolizumab; the Ventana PD-L1 assay was approved by the FDA on May 18, 2016, to detect PD-L1 levels and to help clinicians identify the patients who would most benefit from treatment with atezolizumab. The most common (≥20%) adverse events (all grades) associated with atezolizumab included fatigue (52%), decreased appetite (26%), nausea (25%), urinary tract infection (22%), pyrexia (21%), and constipation (21%). The most common (≥2%) grade 3 or 4 adverse events included urinary tract infection (9%), fatigue (6%), abdominal pain (4%), and dyspnea (4%). Atezolizumab is being evaluated in the confirmatory phase 3 IMvigor 211 study, and is expected to become available for use in early June.

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Afatinib Receives New Indication for Advanced Squamous-Cell NSCLC

On April 15, 2016, the FDA approved afatinib (Gilotrif; Boehringer Ingelheim) tablets for the oral treatment of patients with advanced squamous-cell carcinoma of the lung that has progressed after platinum-containing chemotherapy treatment. Afatinib was already approved for the first-line treatment of patients with certain EGFRmutation–positive non–small-cell lung cancer. Advanced squamous-cell carcinoma of the lung has a median overall survival of approximately 1 year after diagnosis and is characterized by a poor prognosis. The approval was based on the LUX-Lung 8 head-to-head clinical trial comparing afatinib with erlotinib (Tarceva) in patients with squamous-cell carcinoma of the lung whose tumors progressed after first-line chemotherapy. Compared with erlotinib, afatinib demonstrated an 18% reduction in the risk for cancer progression and a 19% reduction in the risk for death. There was also a significant improvement in the disease control rate with afatinib versus with erlotinib (51% vs 40%, respectively; P = .002). The most common (in ≥20% of patients) adverse events observed with afatinib were diarrhea (75%), rash or acne (70%), stomatitis (30%), decreased appetite (25%), and nausea (21%). The LUX-Lung 8 trial is part of the LUX-Lung program, which is a collection of 8 clinical studies involving more than 3760 patients. “We are pleased to bring a proven therapy to patients suffering from advanced squamous cell carcinoma of the lung who have progressed despite chemotherapy,” said Sabine Luik, MD, Senior Vice President, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “This approval is further evidence of Boehringer Ingelheim’s strong commitment to bringing new treatment options to the lung cancer community.”

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FDA Approves Netspot Diagnostic Test to Detect Neuroendocrine Tumors

On June 1, 2016, the FDA approved Netspot (Advanced Accelerator Applications USA), a diagnostic test to detect somatostatin receptor–positive neuroendocrine tumors (NETs). The radioactive diagnostic agent gallium (Ga)-68 dotatate injection is available as a single-dose injection and is used in conjunction with positron emission tomography imaging to aid in locating these tumors in adults and in pediatric patients. The FDA previously granted an orphan drug designation and priority review status to Netspot. NETs develop in neuroendocrine cells throughout the body, including in the stomach, intestines, pancreas, and lungs. Ga-68 dotatate works by binding to somatostatin receptors; somatostatin is the hormone that regulates the endocrine system. “Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical,” said Libero Marzella, MD, PhD, Director of the FDA’s Division of Medical Imaging Products. “Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. This information is important for planning the appropriate course of therapy.” The safety and effectiveness of Netspot were established in 3 clinical studies. In the first study, images using Ga-68 dotatate and an approved drug were compared and then confirmed with computed tomography scans or with magnetic resonance imaging. In the second study, images using Ga-68 dotatate were evaluated by histopathology. The third study evaluated patients with recurrent NET using Ga-68 dotatate images. The findings from all 3 studies confirmed the efficacy of Ga-68 dotatate imaging in locating NETs. No serious adverse events were identified during the trials; however, the FDA notes that Netspot does add to patients’ overall long-term cumulative radiation exposure. The FDA encourages patients to drink and urinate as much as possible in the first hours after the administration of the diagnostic agent, to reduce the risk.

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