The Committee for Medicinal Products for Human Use has recommended the first-line approval of bevacizumab (Avastin) in combination with erlotinib (Tarceva) for patients with advanced or metastatic EGFR-mutant non-small cell lung cancer.
A number of novel therapies are currently being explored as second-line treatments for patients with advanced hepatocellular carcinoma, including a host of targeted therapies and various immune checkpoint inhibitors.
With nearly a dozen new PI3K and BTK inhibitors currently in development for patients with relapsed chronic lymphocytic leukemia it is challenging to know which therapies are truly "next-generation" agents and which are "me too" products.
Nivolumab (Opdivo) has been granted a breakthrough therapy by the FDA as a treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) following a platinum-based therapy.
The phase III PALOMA-2 trial has shown a significant improvement in progression-free survival (PFS) for the frontline combination of palbociclib (Ibrance) and letrozole compared letrozole alone for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
The FDA has granted a breakthrough therapy designation to pembrolizumab (Keytruda) as a treatment for patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
Novel combination approaches are currently under exploration that hope to capitalize on the varying mechanisms of action for each newly approved agent for men with metastatic castration-resistant prostate cancer (mCRPC).
Single-agent nivolumab (Opdivo) demonstrated a robust 5-year overall survival (OS) rate of 34% for heavily pretreated patients with metastatic melanoma who had not received prior ipilimumab (Yervoy), according to long-term findings from a single-arm phase I study.
Treatment with the novel multikinase inhibitor entrectinib achieved objective responses in 79% of patients with solid tumors associated with NTRK, ROS-1, or ALK rearrangements.
The FDA has granted a priority review designation to pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) following a platinum-based chemotherapy, according to a statement from Merck, the company developing the PD-1 inhibitor.
Immunotherapy should be considered along with VEGF and mTOR TKIs as a highly effective treatment modality for patients with metastatic renal cell carcinoma (RCC).
Following a series of meetings with the FDA, Puma Biotechnology announced that it plans to delay the submission of a new drug application (NDA) until mid-2016 for neratinib.
An upcoming FDA decision for the PD-L1 inhibitor atezolizumab as a treatment for patients with bladder cancer could set the stage for an onslaught of new and highly effective immuno-oncology agents, according to Daniel Petrylak, MD.
Despite the letdown of prior research, the future looks bright for immunotherapies and novel targeted approaches for patients with gliomas, many of which have already been developed for other types of cancer.
Treatment with gefitinib (Iressa) failed to show noninferiority compared with erlotinib (Tarceva) for patients with pretreated non-small cell lung cancer (NSCLC).
A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug's developer, Lexicon Pharmaceuticals.
The FDA has approved defibrotide sodium (Defitelio) as a treatment for severe hepatic veno-occlusive disease (VOD) with associated kidney or lung abnormalities following hematopoietic stem cell transplantation (HSCT), based on data from the collection of 3 studies.
Liposomal irinotecan (irinotecan liposome injection; Onivyde), fluorouracil (5-FU), and leucovorin in combination 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.
Trabectedin (Yondelis) improved progression-free survival (PFS) when compared with dacarbazine in women with advanced uterine leiomyosarcoma, according to a subgroup analysis of the phase III SAR-3007 trial.
An abiraterone acetate (Zytiga) plus prednisone combination showcased an 11.8-month improvement in overall survival (OS) when compared with prednisone and placebo in less advanced, chemotherapy-naive metastatic castration-resistant prostate cancer.
Captisol-enabled (CE) melphalan (Evomela) has been approved by the FDA as a high-dose conditioning treatment for patients with multiple myeloma prior to autologous stem cell transplantation (ASCT).
The PD-L1 inhibitor atezolizumab has gained priority review status from the FDA as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC).
Six ongoing clinical trials investigating several idelalisib (Zydelig) combinations have been halted due to reports of increased adverse events such as death for patients with hematologic malignancies, according to an alert issued by the FDA.
The FDA has recieved a supplemental new drug application for a combination of ofatumumab (Arzerra), fludarabine, and cyclophosphamide, for patients with relapsed chronic lymphocytic leukemia (CLL).
The addition of Yttrium-90 (Y-90) resin microspheres (SIR-Spheres) to standard frontline FOLFOX-based chemotherapy with or without bevacizumab significantly improved liver-specific progression-free survival (PFS) for patients with liver metastatic colorectal cancer (CRC), according to findings from the phase III SIRFLOX study published in the Journal of Clinical Oncology.
Crizotinib (Xalkori) has been approved by the FDA for patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC), based on substantial efficacy displayed in a phase I study.
A supplemental new drug application for pembrolizumab for advanced non-small cell lung cancer (NSCLC) with PD-L1 expression on ≥1% of tumors cells has been submitted to the FDA.
The combination of rindopepimut plus temozolomide did not improve overall survival (OS) when compared with temozolomide plus a control in patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme (GBM).
Tremelimumab as a monotherapy in both the second- and third-line treatment failed to boost overall survival (OS) compared with placebo for patients with unresectable malignant mesothelioma.
In the study, the bavituximab combination showed OS data similar to expectations while patients in the docetaxel-alone arm "dramatically outperformed OS expectations," according to Peregrine Pharmaceuticals.