Silas Inman

The FDA has granted MM-398 (nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin a Fast Track designation as a second-line treatment for patients with metastatic pancreatic cancer

Frontline treatment with nivolumab significantly extended OS and PFS compared with dacarbazine in patients with untreated BRAF wild-type advanced melanoma.

The PD-1 inhibitor pembrolizumab significantly improved PFS by over 43% compared with chemotherapy as a treatment for patients with metastatic melanoma who were refractory to ipilimumab.

The FDA has approved bevacizumab in combination with chemotherapy for patients with recurrent platinum-resistant ovarian cancer.

Frontline treatment with neratinib in combination with paclitaxel demonstrated similar ORR and PFS as the combination of trastuzumab and paclitaxel while lowering the incidence of CNS metastases in patients with locally recurrent or metastatic HER2-positive breast cancer.

Access to radium-223 dichloride has been restored following a temporary suspension in production by its manufacturer Bayer HealthCare Pharmaceuticals to adjust its manufacturing process to meet certain quality standards that the company has in place.

In what was described as a very difficult decision, ODAC voted 5-2 against the accelerated approval of the HDAC inhibitor panobinostat in combination with bortezomib and dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy.

The addition of the GM-CSF agent sargramostim to the CTLA-4 inhibitor ipilimumab (Yervoy) prolonged overall survival (OS) and lowered toxicity for patients with unresectable stage III or IV melanoma

The FDA has approved the combination of ramucirumab and paclitaxel as a treatment for patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma.

The combination of paclitaxel and the angiogenesis inhibitor trebananib did not demonstrate a statistically significant improvement in overall survival when compared with paclitaxel alone for patients with recurrent platinum-resistant ovarian cancer.

A novel first-in-class covalent KRAS inhibitor SML-8-73-1 has demonstrated promise in preclinical studies, prompting a 3-year research collaboration between the Dana-Farber Cancer Institute and Astellas Pharma Inc.

Treatment with eribulin mesylate improved overall survival of patients with triple-negative and HER2-negative metastatic breast cancer compared with standard chemotherapies.

The impact of RAI on long-term outcomes, potential combination strategies, molecular profiling, and novel therapeutics for patients with thyroid cancer were among some of the topics highlighted at the 2014 ATA Annual Meeting.

Molecular profiling has revealed several tumor markers that could be utilized as therapeutic targets for patients with small cell lung cancer (SCLC) or lung neuroendocrine tumors (NETs).

The FDA has granted a fast track designation to TAS-102 (tipiracil hydrochloride) as a treatment for patients with refractory metastatic colorectal cancer (mCRC), according to an announcement by Taiho Oncology, the company developing the drug in the United States.

The treatment of patients with chronic lymphocytic leukemia (CLL) has undergone a dramatic transformation in the past year, with the approval of the novel oral agents ibrutinib (Imbruvica) and idelalisib (Zydelig).

The FDA has granted a priority review to the oral multiple tyrosine kinase receptor inhibitor lenvatinib as a treatment for patients with progressive, radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC), according to the manufacturer of the drug, Eisai.

ASCO has endorsed the CAP/IASLC/AMP guideline on molecular testing for patients with lung cancer, which recommends EGFR and ALK testing for all patients with lung adenocarcinoma or mixed histology with an adenocarcinoma component.

The FDA has assigned a priority review designation to palbociclib in combination with letrozole as a frontline treatment for postmenopausal patients with ER-positive, HER2-negative advanced breast cancer.

Treatment with the mTOR inhibitor everolimus improved overall survival by 6.34 months over placebo for patients with pancreatic neuroendocrine tumors.

The FDA has assigned a priority review designation to blinatumomab as a treatment for adult patients with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.

The FDA has scheduled an ODAC advisory hearing to discuss the new drug application for panobinostat in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

The FDA has expanded the approval for bortezomib (Velcade) to include the frontline treatment of patients with mantle cell lymphoma.

A clinical trial collaboration between Novartis and BMS has resulted in the establishment of several novel combination trials involving the PD-1 inhibitor nivolumab and targeted therapies against ALK, c-MET, and T790M for patients with NSCLC.

The highly selective ALK inhibitor AP26113 has been granted a Breakthrough Therapy Designation by the FDA for the treatment of patients with ALK-positive metastatic NSCLC who received prior treatment with crizotinib.

The combination of abiraterone acetate and prednisone has demonstrated a statistically significant improvement in overall survival (OS) for men with metastatic castration-resistant prostate cancer (mCRPC) who had not received prior treatment with chemotherapy

Treatment with crizotinib (Xalkori) demonstrated an overall response rate (ORR) of 72% in patients with ROS1-rearranged non–small cell lung cancer (NSCLC), according to phase I data presented at the 2014 ESMO Congress and published in The New England Journal of Medicine.

The FDA has assigned a priority review designation to the PD-1 inhibitor nivolumab (Opdivo) as a treatment for pretreated patients with advanced melanoma.

Treatment with the combination of bevacizumab and chemotherapy improved PFS and OS in women with HER2-negative metastatic breast cancer.

The combination of ABT-199 and ibrutinib (Imbruvica) demonstrated promising early activity in mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) cell lines