Silas Inman

Nivolumab and elotuzumab have each been granted breakthrough therapy designations by the FDA for the treatment of two types of blood cancers.

The ASCO clinical practice guideline now recommends treatment with adjuvant tamoxifen for 10 years in women with stage I-III hormone receptor (HR)-positive breast cancer.

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.

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.

The highly selective EGFR inhibitor AZD9291 demonstrated an ORR of 64% without inducing dose-limiting toxicities in patients with metastatic NSCLC who harbor an acquired EGFR T790M resistance mutation.

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 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.

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

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 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.

The most promising novel therapeutics in development for patients with breast cancer focus primarily on targeting activating mutations in combinations that are based on findings from next-generation sequencing.

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.

In the largest gastric cancer second-line trial, the VEGFR-2 inhibitor ramucirumab combined with paclitaxel demonstrated a significant increase in survival.