News

The FDA has approved panitumumab (Vectibix) in combination with chemotherapy as a frontline treatment for patients with <em>KRAS</em> wild-type metastatic colorectal cancer (mCRC), based on findings from two phase III clinical trials.

A cell-cycle gene array test demonstrated independent value for predicting metastatic progression after surgery for organ-confined renal cell carcinoma (RCC) of clear cell histology.

The EGFR inhibitor CO-1686 has received a breakthrough therapy designation from the FDA for its potential as a treatment for patients with metastatic T790M mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of EGFR-targeted therapy.

A phase III study exploring the chemotherapy regimen DHAP plus ofatumumab failed to meet its primary endpoint of prolongation in PFS when compared with DHAP plus rituximab for patients with relapsed or refractory DLBCL.

Despite improved efficacy with new therapies, both as monotherapy or in combinations, they provide new challenges to nurses in managing side effects and adjusting treatment.

Treatment with the investigational oral agent TAS-102 significantly improved overall survival (OS) in a phase III trial for patients with heavily pretreated metastatic colorectal cancer (mCRC).

The combination of vemurafenib with the investigational MEK inhibitor cobimetinib demonstrated a 13.7-month median PFS and an ORR of 87% in treatment-naïve patients with BRAFV600 mutation-positive metastatic melanoma.

The FDA has assigned a priority review designation to the PD-1 inhibitor pembrolizumab (MK-3475) as a treatment for patients with unresectable or metastatic melanoma following progression on ipilimumab.

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.

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 FDA’s Molecular and Clinical Genetics advisory committee has unanimously supported the safety, efficacy, and positive risk-benefit profile of the noninvasive stool-based DNA test Cologuard in a 10-0 vote.

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.