News

The FDA has granted a breakthrough therapy designation to pembrolizumab (Keytruda) as a treatment for patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

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 approved afatinib for the treatment of patients with advanced squamous cell non-small cell lung cancer following progression on platinum-based chemotherapy.

Patients with non-small cell lung cancer (NSCLC) who had ceased to respond to EGFR TKI therapy demonstrated a rapid and robust response to the investigational agent BI-1482694 (HM61713).

The FDA has granted nivolumab (Opdivo) a priority review for use in previously treated patients with classical Hodgkin lymphoma (cHL), giving the drug the potential to become the first PD-1 inhibitor approved for a hematologic malignancy.

Treatment with ensituximab (NPC-1C), a chimeric IgG1 monoclonal antibody, induced stable disease in nearly half of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC) without contributing significant toxicity.

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).

PD-1/PD-L1 should be the backbone of melanoma treatment for many patients, says Jason Luke, MD, an assistant professor of Medicine at the University of Chicago Medicine.

The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 12-1 against the accelerated approval of rociletinib for patients with metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) who have previously received an EGFR-targeted therapy.

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.

The FDA has granted a priority review to atezolizumab for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who express PD-L1 and have progressed after a platinum-containing regimen.

The FDA approved the BCL-2 inhibitor venetoclax (Venclexta) for patients with chronic lymphocytic leukemia (CLL) who have a 17p deletion (del[17p]), following at least 1 prior therapy.

Multiple targeted therapies have shown promising signs of efficacy for patients with acute myeloid leukemia (AML), including the FLT3 inhibitor midostaurin and novel IDH inhibitors, with the ongoing potential for combination strategies in the future, according to Eytan M. Stein, MD.

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.

The multikinase inhibitor lenvatinib (Lenvima) has quickly become the frontline standard of care for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), just one year following its initial approval, according to Renato Martins, MD.

Treatment with gefitinib (Iressa) failed to show noninferiority compared with erlotinib (Tarceva) for patients with pretreated non-small cell lung cancer (NSCLC).

Adding plitidepsin (Aplidin) to dexamethasone reduced the risk of disease progression by 35% versus dexamethasone alone in patients with relapsed/refractory multiple myeloma enrolled in the phase III ADMYRE trial.

In an interview with Targeted Oncology, Sarah Goldberg, MD, MPH, assistant professor of Medicine and Medical Oncology, Yale Cancer Center, discussed the efficacy of immunotherapies, PD-L1 as a biomarker, and how these therapies will continue to alter the treatment of patients with lung cancer.

In an interview with Targeted Oncology, Edward Kim, MD, discussed the FDA-approved immunotherapies nivolumab and pembrolizumab along with potential combinations, biomarkers, and ongoing research.

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.

The combination of the PD-L1 inhibitor durvalumab and the CTLA-4 inhibitor tremelimumab, showed antitumor activity in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), irrespective of PD-L1 status, according to a recent phase Ib study published in The Lancet Oncology.

Second-line treatment of metastatic pancreatic cancer, after first-line treatment with nab-paclitaxel plus gemcitabine or gemcitabine alone, is feasible and may improve outcomes, according to a post-hoc analysis of the phase 3 MPACT trial presented at the 2016 Gastrointestinal Cancers Symposium.

Three different chemotherapy regimens, each combined with bevacizumab, failed to demonstrate an advantage for patients with advanced ovarian cancer or build on results of a landmark trial reported more than a decade ago.

An ongoing clinical trial has begun the process of evaluating whether the addition of a booster agent can take the anticancer activity of PD-1 directed immunotherapy to another level.

New technology and improvements in administration techniques could make the utilization of stereotactic body radiation therapy easier and more plausible for patients with pancreatic cancer, according to Joseph Michael Herman, MD.

The panel, which included experts in oncology, dentistry, nursing, speech pathology, and primary care, conducted a systematic literature review to develop these consensus-based management strategies for HNC survivors. Their search identified 2081 articles, of which 184 were ultimately included in the evidence base.

A subgroup analysis of the phase III SAR-3007 trial demonstrating the efficacy of trabectedin (Yondelis) in patients with advanced uterine leiomyosarcoma bodes well for the malignancy's armamentarium, according to Martee L. Hensley, MD.