Silas Inman

A new drug application has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors.

Puma Biotechnology announced that it plans to delay the submission of a new drug application until mid-2016 for neratinib as an extended adjuvant treatment for patients with HER2-positive early breast cancer following a trastuzumab-based regimen.

The FDA has approved defibrotide sodium as a treatment for severe hepatic veno-occlusive disease with associated kidney or lung abnormalities following hematopoietic stem cell transplantation.

Treatment with gefitinib failed to show noninferiority compared with erlotinib for patients with pretreated non–small cell lung cancer.

The combination of liposomal irinotecan (irinotecan liposome injection; Onivyde), fluorouracil, and leucovorin has been added to the 2016 NCCN Clinical Practice Guidelines in Oncology as a second-line treatment for patients with gemcitabine-refractory metastatic pancreatic cancer.

Chimeric antigen receptor-modified T-cell therapies have demonstrated durable complete responses for patients with relapsed/refractory B-cell acute lymphoblastic leukemia; however, several questions remain regarding their optimal use and applicability outside of this disease.

Extended follow-up data continue to demonstrate the efficacy and tolerability of ibrutinib in previously treated patients with chronic lymphocytic leukemia, including those with high-risk gene mutations and prognostic features.

Immuno-oncology has advanced rapidly, with the introduction of immune checkpoint inhibition and effective adoptive T-cell therapies. As these agents rush through development, several questions remain regarding the optimal patients for treatment and the next steps for further improving outcomes.

A multitude of PI3K and BTK inhibitors are currently in development that offer distinct advantages over existing treatments for patients with relapsed chronic lymphocytic leukemia.

A host of novel agents are on the horizon that could further improve the long-term outcomes experienced by patients with follicular lymphoma, particularly those with relapsed or refractory disease.

Frontline treatment with ibrutinib reduced the risk of progression or death by 84% compared with single-agent chlorambucil for elderly patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

A supplemental new drug application has been submitted to the FDA for ofatumumab in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia.

Six clinical trials exploring idelalisib in combination other therapies for patients with hematologic malignancies have been halted due to reports of an increased rate of adverse events, including death.

Treatment with abiraterone acetate plus prednisone demonstrated an 11.8-month improvement in overall survival compared with prednisone and placebo for men with less advanced, chemotherapy-naïve metastatic castration-resistant prostate cancer.

A number of crucial findings were presented over the course of 2015 that helped to characterize an ever-growing trend toward personalized medicine in the treatment of breast cancer.

Pathologic complete response may still have a role in accelerated neoadjuvant approvals for select patients with early stage breast cancer, despite the fact that it remains an unproven surrogate endpoint.

The combination of the alpha-specific PI3K inhibitor alpelisib (BYL719) and fulvestrant (Faslodex) demonstrated promising early efficacy and mild toxicity in heavily pretreated postmenopausal women with ER-positive metastatic breast cancer.

The FDA has approved crizotinib as a treatment for patients with ROS1-positive metastatic non–small cell lung cancer.

The FDA has accepted a supplemental new drug application for pembrolizumab as a treatment for patients with advanced non–small cell lung cancer with PD-L1 expression on ≥1% of tumors cells.

Treatment with rindopepimut (Rintega) plus temozolomide failed to improve overall survival compared with temozolomide and a control for patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme.

Chimeric antigen receptor-modified T-cell therapies continue to demonstrate promising signs of efficacy for patients with hematologic malignancies, including those with acute lymphoblastic leukemia and non-Hodgkin lymphoma.

Second- or third-line treatment with tremelimumab monotherapy failed to improve overall survival compared with placebo for patients with unresectable malignant mesothelioma.

The FDA has approved everolimus for the treatment of adult patients with progressive, well-differentiated non-functional, locally advanced or metastatic gastrointestinal or lung neuroendocrine tumors.

The phase III SUNRISE trial comparing bavituximab plus docetaxel with docetaxel and placebo for patients with non–small cell lung cancer has been halted following a futility analysis.

The FDA has granted midostaurin a breakthrough therapy designation as a potential treatment for adult patients with newly diagnosed FLT3-mutated acute myeloid leukemia.

Concurrent chemoradiation significantly improved overall survival compared with radiation therapy alone for elderly patients with locally advanced head and neck cancers.

The FDA has granted a breakthrough therapy designation to durvalumab as a treatment for patients with PD-L1–positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.

The FDA has placed a full clinical hold on trials exploring pacritinib, following reports of patient deaths related to intracranial hemorrhage, cardiac failure, and cardiac arrest in the phase III PERSIST-2 trial.

The FDA has scheduled an ODAC advisory hearing for April 12, 2016, to discuss the new drug application for rociletinib as a treatment for patients with metastatic EGFR T790M-mutated non–small cell lung cancer.

Treatment with the tyrosine kinase inhibitor neratinib demonstrated a 2-year disease-free survival rate of 93.9% in patients with early-stage HER2-positive breast cancer, representing a 33% improvement compared with placebo.