News

Updates on dabrafenib, trametinib, lambrolizumab, and more.

Ibrutinib (Imbruvica) has received an FDA approval to include the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one previous therapy.

There are currently numerous experimental therapeutic options in various phases of clinical development that may hold promise for patients with advanced melanoma.

Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of MK-3475 across multiple tumor types. The agreements were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.

The intravenous pan-HDAC inhibitor belinostat (Beleodaq) as a treatment for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) has received a priority review designation from the FDA.

The FDA has granted a Breakthrough Therapy designation for the small molecule thrombopoietin receptor (TPOR) agonist eltrombopag (Promacta) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy.

Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is a microtubule inhibitor.

The investigational agent lenvatinib (E7808) met its primary endpoint of progression-free survival (PFS) in the phase III SELECT trial, which compared lenvatinib to placebo in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC),according to Eisai Inc., the company that is developing the agent.

Palbociclib plus letrozole is tolerable and more than doubles progression-free survival (PFS) for postmenopausal patients with locally advanced or newly diagnosed estrogen receptor (ER)-positive, HER2-negative metastatic breast cancer, according to final results from the phase II PALOMA-1 trial

The FDA has granted a Breakthrough Therapy designation to dabrafenib for its potential as a treatment for patients with metastatic BRAF V600E mutation-positive NSCLC who have received at least one prior line of platinum-containing chemotherapy.

The combination of the MEK inhibitor trametinib (Mekinist) and the BRAF inhibitor dabrafenib (Tafinlar) has received an accelerated approval from the FDA as a treatment for patients with unresectable or metastatic melanoma who harbor a BRAF V600E or V600K mutation.

This activity is intended to provide an understanding of the optimal use and interpretation of biomarker testing in patients with non-small cell lung cancer.

Belinostat (PXD101), in combination with doxorubicin, could provide benefit for patients with soft tissue sarcomas, according to final results from the first stage of the phase II portion of the phase I/II CLN-14 clinical trial.

The FDA has expanded the approval for sorafenib (Nexavar) to include the treatment of patients with radioactive iodine (RAI)-resistant metastatic differentiated thyroid cancer (DTC).

Aldoxorubicin demonstrated response rates that culminated in a higher incidence of stable disease versus doxorubicin as a first-line treatment for advanced soft tissue sarcomas, according to results from an ongoing phase IIb study.

The investigational anti-PD-1 immunotherapy MK-3475 has demonstrated an overall survival rate of 81% at one year in patients with advanced melanoma.

AGS-003, an investigational autologous dendritic cell vaccine, successfully activated a cytotoxic T cell response that correlates with a prolongation in survival for patients with metastatic renal cell carcinoma (mRCC), according to an analysis presented at the 2013 Annual Meeting of the Society for Immunotherapy of Cancer.

The FDA has granted an accelerated approval to ibrutinib as a treatment for patients with mantle cell lymphoma who have received at least one prior therapy, based on a single-arm clinical trial demonstrating a durable improvement in ORR.

Obinutuzumab (Gazyva) plus chlorambucil has been approved by the FDA as a first-line treatment for patients with CLL, based on clinical trial data demonstrating that the combination more than doubled median PFS over the chemotherapy agent alone.

Marketing and commercial distribution of ponatinib (Iclusig) has been temporarily suspended, following an ongoing FDA investigation that revealed an increased frequency of severe arterial thrombosis and stenosis.

Hyperfractionated radiotherapy demonstrated a superior improvement in overall survival rates compared to standard and accelerated radiotherapy when administered without concomitant chemotherapy in patients with locally advanced HNSCC.

The PD-1 blocking antibody nivolumab continues to demonstrate clinical activity in previously treated patients with advanced non-small cell lung cancer (NSCLC), according to updated long-term survival data from a phase I trial.

The FDA has assigned a priority review designation to ramucirumab (IMC-1121B) as a second-line treatment for patients with advanced gastric cancer.

A phase III EPIC trial exploring ponatinib (Iclusig) in untreated patients with chronic myeloid leukemia (CML) has been discontinued. The decision comes following a high occurrence of arterial thrombotic events, according to a statement released by Ariad Pharmaceuticals, Inc., the company developing the drug.

Following a positive interim analysis, a phase III study of the PI3K-delta inhibitor idelalisib in combination with rituximab (Rituxan) has been stopped.

The FDA has placed a partial hold on the clinical development of the BCR-ABL inhibitor ponatinib (Iclusig), following the high occurrence of arterial thrombosis in patients treated with the drug.

Updated recommendations for HER2 testing in breast cancer have been released by the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP).

Volasertib (BI 6727) is a potent and selective inhibitor of PLK1 in vitro that is currently being evaluated for its therapeutic potential to target the cell cycle.

MK-3475, an investigational immunotherapy, has demonstrated an objective response rate (ORR) of up to 24% in patients with previously treated non-small cell lung cancer (NSCLC), according to interim results from a phase Ib expansion study.

Results from a pooled analysis of survival data from 12 studies demonstrated long-term survival benefit in patients with metastatic or locally advanced or unresectable melanoma treated with ipilimumab (Yervoy).