News

The FDA Department of Orphan Products Development has granted orphan drug designation to demcizumab (anti-DLL4, OMP-21M18), which is currently in a phase Ib clinical trial in combination with Abraxane® (nab-paclitaxel) and gemcitabine.

The addition of the investigational agent MM-398 (PEP02) to standard second-line chemotherapy significantly improved overall survival (OS) in a phase III trial for patients with metastatic pancreatic cancer.

A novel immunotherapeutic known as IMCgp100 induced clinical responses with manageable toxicity in patients with advanced melanoma.

The FDA has granted an accelerated approval to ceritinib (Zykadia; LDK378) as a treatment for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) following treatment with crizotinib.

The combination of custirsen (OGX-011) with docetaxel and prednisone failed to significantly extend survival as a first-line treatment for men with mCRPC.

The FDA has approved the anti-IL-6 chimeric monoclonal antibody siltuximab (Sylvant) as a treatment for HIV- and HHV-8-negative patients with multicentric Castleman’s disease (MCD).

The FDA has approved ramucirumab as a treatment for patients with unresectable gastric cancer or GEJ adenocarcinoma following fluoropyrimidine- or platinum-containing therapy, based on a significant extension in overall survival (OS).

Talimogene laherparepvec (T-VEC) significantly improved durable response rates (DRR) but failed to extend overall survival (OS) in patients with advanced melanoma.

The FDA has approved ofatumumab (Azerra) plus chlorambucil for previously untreated patients with chronic lymphocytic leukemia (CLL) who are considered inappropriate for treatment with fludarabine therapy.

The adaptive I-SPY 2 trial has found that a neoadjuvant regimen of neratinib and standard chemotherapy is beneficial for high-risk patients with hormone receptor (HR)-negative, HER2-positive stage II/III breast cancer.

The CDK4/6 inhibitor LY2835219 demonstrated promising single-agent activity in heavily pretreated patients with hormone receptor (HR)-positive metastatic breast cancer.

PD-L1 levels adequately predict response and clinical outcomes for PD-1 inhibitor MK-3475 in patients with non-small cell lung cancer (NSCLC) and melanoma.

The combination of palbociclib and letrozole more than doubled PFS and showed a non–statistically significant 4.2-month improvement in OS for patients with ER-positive, HER2-negative metastatic breast cancer.

CO-1686 has demonstrated promising activity without producing many of the side effects traditionally associated with the class of drugs in patients with T790M-mutated non-small cell lung cancer (NSCLC).

The large phase III MAGRIT study investigating the MAGE-A3-specific vaccine GSK1572932A for patients with non-small cell lung cancer (NSCLC) will be completely halted following an interim analysis that demonstrated a lack of benefit.

The US Supreme Court’s landmark decision last June, mandating that an individual’s genes cannot be patented, transformed the genetic testing landscape and opened the marketplace to a host of new and complicated testing options.

The blood-based colorectal cancer (CRC) screening test Epi proColon passed the scrutiny of the FDA’s Molecular and Clinical Genetics advisory panel in a close 5-4 vote with 1 abstention in support of the claim that the test’s benefits outweigh its risks.

The oncolytic immunotherapeutic vaccine talimogene laherparepvec (T-VEC) promoted tumor shrinkage in 64% of patients with advanced melanoma, including a marked reduction in the size of uninjected metastatic lesions.

Nivolumab, a PD-1-specific antibody, has shown to produce long-term remissions with limited toxicity in patients with advanced melanoma, according to results from one of the longest follow ups to examine the drug.

The MAGE-A3-specific immunotherapeutic GSK1572932A failed to significantly extend disease-free survival (DFS) in patients with resected nonmetastatic non-small cell lung cancer (NSCLC) who tested negative for a specific gene expression signature.

Screening for prostate-specific antigen (PSA) significantly cuts the death rate from prostate cancer, but at the same time, America’s medical community should work harder to avoid the screen’s potential pitfalls.

The non-Hodgkin’s lymphomas are a diverse and heterogeneous group of neoplasms most commonly originating in B lymphocytes (80%-85%), but also in T lymphocytes (15%-20%), and, rarely, in natural killer cells.

An exceptional responder with advanced urothelial carcinoma experienced a complete radiologic response lasting 13.8 months following treatment with the combination of everolimus (Afinitor) and pazopanib (Votrient).

New treatments that are currently in development have begun to show promise for patients diagnosed with ALK-positive non-small-cell lung cancer (ALK+ NSCLC), a subset of patients who have historically faced poor outcomes.

Until recently, the cornerstone of therapy for metastatic melanoma had been chemotherapy with dacarbazine (DTIC) and immunotherapy with high-dose interleukin-2 (HD IL-2) or interferon- (IFN- ).

According to a new study, physicians now have a clearer understanding of the optimum age for prophylactic oophorectomy in patients with BRCA mutations who want to reduce their risk of ovarian, fallopian tube, and breast cancer.

The second-line administration of ramucirumab in combination with docetaxel demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared with placebo plus docetaxel in patients with non-small cell lung cancer (NSCLC). The announcement was made Feb. 19 by Eli Lilly and Company, the company developing the agent.

Skin cancer is the most common form of malignancy in the United States, and melanoma represents the most deadly subset.