NEWS HIGHLIGHTSMedia Articles Related to Targretin (Bexarotene)
FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.
Istodax Approved for Cutaneous T-Cell Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.11.09]
Title: Istodax Approved for Cutaneous T-Cell Lymphoma
Category: Health News
Created: 11/6/2009 4:10:00 PM
Last Editorial Review: 11/9/2009
FDA Approves Gloucester Pharmaceuticals' ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.06]
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.
Istodax Approved for Cutaneous T-Cell Lymphoma (HealthDay)
Source: Y! Health Lymphoma News [2009.11.06]
HealthDay - FRIDAY, Nov. 6 (HealthDay News) -- The Gloucester Pharmaceuticals
drug Istodax (romidepsin) has been approved by the U.S. Food and Drug
Administration to treat cutaneous T-cell lymphoma (CTCL) in people who
have tried at least one prior systemic therapy, the drug's manufacturer
said in a news release.
FDA Okays New Treatment for T-Cell Lymphoma
Source: MedPage Today Product Alert [2009.11.06]
WASHINGTON (MedPage Today) -- The FDA has approved romidepsin (Istodax) for patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy.
Published Studies Related to Targretin (Bexarotene)
Phase I/II randomized bilateral half-head comparison of topical bexarotene 1% gel for alopecia areata. [2009.10]
BACKGROUND: Alopecia areata, hair loss caused by perifollicular T-cell infiltrates, is refractory to therapy. Bexarotene, a retinoid X receptor is a selective retinoid, induces T-cell apoptosis. OBJECTIVE: We sought to determine the safety, including the dose-limiting toxicities with adverse events, and efficacy, ie, response rate, of bexarotene in alopecia areata... CONCLUSION: Topical bexarotene 1% application is well tolerated and possibly effective. A randomized placebo-controlled trial should be conducted.
Randomized phase III trial comparing bexarotene (L1069-49)/cisplatin/vinorelbine with cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT I. [2008.04.10]
PURPOSE: This study evaluated whether the combination of the synthetic rexinoid bexarotene with first-line cisplatin/vinorelbine therapy provides additional survival benefit in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: The addition of bexarotene to first-line chemotherapy did not increase survival in patients with advanced NSCLC. However, a subgroup (32%) of bexarotene-treated patients developing high-grade hypertriglyceridemia appeared to have better survival (12.3 months) than controls; thus triglyceride response may be a biomarker of survival benefit with bexarotene.
Phase III trial comparing carboplatin, paclitaxel, and bexarotene with carboplatin and paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT II. [2008.04.10]
PURPOSE: The purpose of this study was to determine whether addition of the synthetic rexinoid bexarotene (Targretin; Eisai Inc, Woodcliff Lake, NJ) to standard first-line carboplatin and paclitaxel therapy provides additional survival benefit in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: Although the addition of bexarotene to chemotherapy did not improve survival in the overall study population, occurrence of high-grade hypertriglyceridemia in bexarotene-treated patients strongly correlated with increased survival, suggesting that bexarotene may benefit a segment of first-line NSCLC patients.
Phase II clinical trial of bexarotene gel 1% in psoriasis. [2007.05]
We report the results of a nonrandomized, open-label pilot trial investigating the safety, tolerability, and efficacy of bexarotene gel 1% in treating chronic mild to moderate plaque psoriasis. Twenty-four adults with mild to moderate stable plaque psoriasis involving 15% or less of their body surface were enrolled...
Phase II trial of bexarotene capsules in patients with advanced non-small-cell lung cancer after failure of two or more previous therapies. [2006.10.20]
PURPOSE: To evaluate the effect of bexarotene on survival in patients with relapsed non-small-cell lung cancer (NSCLC)... CONCLUSION: In the intent-to-treat population, bexarotene given as third or subsequent line of therapy for relapsed NSCLC did not achieve the intended median survival of 6 months. Survival may have been extended in patients who developed bexarotene-induced hypertriglyceremia and/or skin rash. It is important to confirm these observations in a randomized controlled trial.
Clinical Trials Related to Targretin (Bexarotene)
U19 Project 1 (Targretin Effect on Breast Cancer) [Active, not recruiting]
We want to learn if Targretin has any effect on these markers in breast tissue.
A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer [Active, not recruiting]
The primary aim is to evaluate the safety (Phase I components) of administering bexarotene
(Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin
(Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This
study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral
capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer [Active, not recruiting]
Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in
combination with standard chemotherapy for the treatment of metastatic non-small cell lung
cancer in patients who have not yet received chemotherapy for their lung cancer.
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer [Active, not recruiting]
Ligand Pharmaceuticals Inc. is studying the use of Targretin capsules (bexarotene) in
combination with standard chemotherapy for the treatment of metastatic non-small cell lung
cancer in patients who have not yet received chemotherapy for their lung cancer.
Study of Bexarotene in Patients With Acute Myeloid Leukemia [Completed]
Bexarotene may be useful in the treatment of Acute Myeloid Leukemia (AML). This is the first
study on the use of bexarotene to treat patients with AML. The main purpose of this study is
to establish the proper dose of bexarotene when used to treat AML. The side effect profile
of bexarotene in patients with AML will also be explored.
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