The Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration voted unanimously in support of the approval of GlaxoSmithKline’s pazopanib (Votrient), an investigational oral agent. Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma.
In July 2009, the US Food and Drug Administration (FDA) granted approval for use of the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (Avastin) in combination with interferon alfa for treatment of patients with metastatic renal cell carcinoma (RCC).
Avastin (bevacizumab) plus interferon-alfa has been approved for the treatment of metastatic renal cell carcinoma, according to Genentech. Approval was based on phase III data from the AVOREN study, which showed a 67% increase in progression-free survival (10.2 months) compared to those who received interferon-alfa alone (5.4 months; hazard ratio = 0.60).
Genentech announced that the US Food and Drug Administration (FDA) has approved bevacizumab (Avastin) plus interferon- alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.
Once-daily oral inhibitor of mTOR (mammalian target of rapamycin) for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib (Sutent) or sorafenib (Nexavar).
Patients with advanced renal cell carcinoma who were treated with sunitinib malate (Sutent) experienced a median overall survival of more than two years, compared with patients who took interferon-alpha, according to Pfizer.
Agennix announced that talactoferrin alfa has been granted Fast Track designation by the FDA for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent).
The National Comprehensive Cancer Network (NCCN) has added everolimus (Afinitor) to the NCCN Guidelines for Kidney Cancer as a category 1 option for patients with metastatic renal cell carcinoma following failure of tyrosine kinase inhibitors such as sunitinib (Sutent) and sorafenib (Nexavar). This recommendation comes on the heels of the recent US Food and Drug Administration (FDA) approval of everolimus.
Afinitor (everolimus) has been approved by the FDA for patients with advanced renal cell carcinoma after failure of treatment with sunitinib (Sutent) or sorafenib (Nexavar).
The US Food and Drug Administration (FDA) has approved everolimus (Afinitor) oral tablets for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. Everolimus is intended for patients with advanced renal cell cancer who have already tried another kinase inhibitor (sunitinib [Sutent] or sorafenib [Nexavar]).
A study of nearly 1,500 patients treated for kidney cancer at UCLA in the past 15 years shows that an aggressive, tailored treatment approach results in better survival rates and uncovered subsets of kidney cancer that behave differently and need to be treated accordingly.
The advisory committee tothe UK’s National Health Service(NHS) has recommended that theNHS not pay for four new agentsproven effective in metastatic renalcell carcinoma. The four drugs arebevacizumab (Avastin), sorafenib(Nexavar), sunitinib (Sutent), andtemsirolimus (Torisel).
Patients with advanced renal cell carcinoma (RCC) treated with single-agent, oral sunitinib malate (Sutent) reported experiencing significantly lower severity of symptoms like bone pain and breathlessness, among others, than patients treated with interferon-alfa.
The lead investigator in an evaluation of bevacizumab (Avastin) combined with sunitinib malate (Sutent) for renal cell carcinoma (RCC) said the project would be abandoned. FDA issued a product safety alert after Genentech, Avastin’s developer, reported serious complications in several patients enrolled in the phase I trial.
Radiation therapy (RT) and immunotherapy of cancer both date back more than 100 years, and yet, because radiation was often considered immunosuppressive, there had been little enthusiasm for combining them until recently. Immunotherapy has an established role in the treatment of some cancers-superficial bladder cancer treated with bacillus Calmette-Guérin (BCG), renal cell carcinoma and melanoma treated with interferon and interluekin (IL)-2 (Proleukin), and breast cancer and lymphoma treated with monoclonal antibodies such as trastuzumab (Herceptin) and rituximab (Rituxan), which partly function through antibody-dependent cellular cytotoxicity.
Wyeth Pharmaceuticals recently announced the initiation of the INTORACT (INvestigation of TORisel and Avastin Combination Therapy) study, a worldwide randomized, open-label, phase IIIB study comparing temsirolimus (Torisel) plus bevacizumab (Avastin) vs bevacizumab plus interferon-alfa for first-line treatment of patients with advanced renal cell carcinoma (RCC). Wyeth Research is conducting the INTORACT study with the support and assistance of Roche and Genentech
COLLEGEVILLE, Pennsylvania-Wyeth Pharmaceuticals has initiated the INTORACT (Investigation of Torisel and Avastin Combination Therapy) trial, a worldwide randomized open-label phase IIIb study comparing temsirolimus (Torisel) plus bevacizumab (Avastin) vs bevacizumab plus interferon-alfa for the first-line treatment of patients with advanced renal cell carcinoma.
A multicenter study has found that the experimental targeted therapy everolimus (Cetican, RAD001) delays cancer progression in patients with metastatic kidney cancer that has progressed despite treatment with other targeted therapies. Lead author Robert J. Motzer, md, attending physician at Memorial Sloan-Kettering Cancer Center, presented the results at the ASCO meeting (abstract LBA5026).
CHICAGO-Everolimus prolongs progression-free survival in patients with metastatic renal cell carcinoma that has progressed despite treatment with inhibitors of the vascular endothelial growth factor (VEGF) receptor tyrosine kinase, finds an international phase III trial (RECORD-1) presented at ASCO 2008 (abstract LBA-5026).
NEW YORK-Antigenics Inc.’s personalized cancer vaccine Oncophage (vitespen) has received its first government approval.
Epothilones, representing a newer class of naturally occurring antimicrotubule macrolides, have emerged as cytotoxic agents with significant antitumor activity against tumors that are resistant to taxanes.
Ms. Donovan and Dr. Vahdat present a review of the literature on a novel class of agents, the epothilones, focusing in particular on the two most-investigated agents to date-patupilone and ixabepilone (Ixempra).
The introduction of imatinib mesylate (Gleevec) has dramatically changed the management and prognostic outlook of patients with chronic myeloid leukemia (CML).
Drs. Rini and Bukowski do an excellent job of updating and commenting on the rapidly evolving field of therapy for metastatic renal cell carcinoma (RCC).
Renal cell carcinoma (RCC) has been considered one of the most difficult tumors to treat for about 20 years. Chemotherapy and radiotherapy have almost no efficacy in this tumor, and cytokines (interleukin [IL]-2 [Proleukin] and interferon) have remained the only available treatment for about 20 years, with a small proportion of patients benefiting from these treatments.
