Temozolomide + RT boosts survival in elderly with glioblastoma
CHICAGO – Adding concomitant and adjuvant temozolomide to a shorter course of radiotherapy (RT) for elderly patients with glioblastoma improves progression-free survival, according to a phase III... (Source: Clinical Neurology News)
Source: Clinical Neurology News - June 10, 2016 Category: Neurology Source Type: news
Age Not an Issue: Chemo Also for Elderly GlioblastomaAge Not an Issue: Chemo Also for Elderly Glioblastoma
The first trial specifically in elderly patients with glioblastoma, most of whom were over 70, shows that temozolomide plus radiation improves survival also in this patient population. Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - June 6, 2016 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
'Huge' Survival Benefit, New Standard of Care in Glioma'Huge' Survival Benefit, New Standard of Care in Glioma
Adding adjuvant temozolomide to radiotherapy for patients with grade 3 anaplastic glioma without the 1p/19 deletion is a new standard of care. Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - June 5, 2016 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news
A new frontier in the war on brain cancer with NovoCure chairman Bill Doyle
Novocure, the St. Helier, Jersey-based medical device company, which raised more than $158M in an IPO last year, is trying to change the way we fight cancer.
Company officials say its proprietary Tumor Treating Fields technology, marketed under the product name Optune, are a new tool in the war against cancer. Currently, the company has FDA approval for Glioblastoma, the deadliest form of brain cancer.
The results thus far have been impressive for Novocure. In December, data from the company’s pivotal phase 3 trial of its Optune device, published in the Journal of the American Medical Association, showed that Op...
Source: Mass Device - April 26, 2016 Category: Medical Equipment Authors: Brian Johnson Tags: Device Talks Podcasts NovoCure Source Type: news
Novocure wins reimbursement from Humana for Optune brain cancer device
NovoCure (NSDQ:NVCR) said today it won reimbursement from Humana for treatments with its Optune device for patients with recurrent glioblastoma.
The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields,” to inhibit cancer cell replication and cause cancer cell death.
The new reimbursement win brings the number of commercial payers covering Optune treatment up to 9, NovoCure said in a press release.
In January, NovoCure said it applied for a supplemental pre-market approval from the FDA for the 2nd generation of its O...
Source: Mass Device - March 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Oncology NovoCure Source Type: news
Lannett Receives FDA Approval For Temozolomide Capsules
PHILADELPHIA, Feb. 11, 2016 -- (Healthcare Sales & Marketing Network) -- Lannett Company, Inc. (LCI) today announced that its wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc. (KU), has received approval from the U.S. Food and Drug Administratio... Biopharmaceuticals, Generics, FDALannett Company, Kremers Urban Pharmaceuticals, Temozolomide, Temodar (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 11, 2016 Category: Pharmaceuticals Source Type: news
New Mesothelioma Clinical Trial Hopes to Improve Chemotherapy
This study is part of a broad development program that includes a number of additional planned studies."
TRACON Pharmaceuticals develops novel targeted cancer therapies. Its TRC105 antibody is directed at renal cell carcinoma and hepatocellular carcinoma.
This clinical trial with TRC102 is one of five nationally involving methoxyamine, but one of more than 200 trials for mesothelioma. (Source: Asbestos and Mesothelioma News)
Source: Asbestos and Mesothelioma News - January 27, 2016 Category: Environmental Health Authors: Tim Povtak Tags: Research & Clinical Trials Source Type: news
NovoCure touts JAMA publication of Optune trial data
NovoCure (NSDQ:NVCR) said today data from the pivotal phase 3 trial of its Optune device, in combination with standard-of-care temozolomide, for treating newly diagnosed glioblastoma has been published in the Journal of the American Medical Association.
The results from the EF-14 trial reported that Optune along with temozolomide significantly extended progression-free survival and overall survival compared to temozolomide alone in treating newly diagnosed glioblastoma.
“The EF-14 data are spectacular. They support Tumor Treating Fields as a new standard of care for patients suffering from glioblastoma. These result...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Oncology Clinical Trials NovoCure Source Type: news
Tumor-Treating Fields Up Survival in GlioblastomaTumor-Treating Fields Up Survival in Glioblastoma
In the treatment of glioblastoma, electromagnetic field therapy with temozolomide improves progression-field survival and median overall survival. Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 15, 2015 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news
Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:
Summary of PMA Originals & Supplements Approved
Originals: 9
Supplements: 133
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 597
Total Active: 433
Total On Hold: 164
Summary of All PMA Submissions
Originals: 7
Supplements: 74
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 133
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 161.5
FDA Time: ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
NovoCure’s cancer therapy effective in late-stage study
(Reuters) – NovoCure (NSDQ:NVCR) said its lead cancer therapy improved survival rate in brain cancer patients in combination with Avastin in a late-stage study, sending its shares up 23% in extended trading.
NovoCure’s therapy, Optune, which was evaluated in combination with Roche Holding AG’s cancer drug, reduced the risk of death by 39% in patients, compared with patients treated with Avastin alone, Novocure said in a statement on Friday.
Optune is an FDA-approved device for use in patients with glioblastoma multiforme (GBM), the most common and aggressive form of brain tumor in which 90% of adult patients...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Business/Financial News Clinical Trials NovoCure Source Type: news
NovoCure wins expanded indications for Optune brain tumor-zapping device
NovoCure said it won expanded indications from the FDA and a new CE Mark indication in the European Union for its brain-tumor treating Optune device.
The Optune device uses NovoCure’s “tumor treating fields,” which use low-intensity, intermediate-frequency alternating electric fields that limit cancer cell replication and kill cancer cells, the St. Helier, N.J.-based company said.
The FDA granted NovoCure clearance for its Optune in combination with prescribed temozolomide for the treatment of adult patients with newly diagnosed glioblastomas.
“Novocure is committed to helping patients with glioblastoma...
Source: Mass Device - October 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Oncology Radiosurgery Regulatory/Compliance NovoCure Source Type: news
FDA Approves Optune In Combination With Temozolomide For The Treatment Of Newly Diagnosed Glioblastoma
Novocure has announcedthat the FDAhas approved Optune in combination with temozolomide for the treatment of adult patients with newly diagnosed glioblastoma (GBM). Optune is a portable, non-invasive device that delivers low-intensity, intermediate frequency, alternating electric fields – referred to as Tumor Treating Fields (TTFields) – that inhibit cancer cell replication and cause cancer cell death. (Source: Medical Design Online News)
Source: Medical Design Online News - October 6, 2015 Category: Medical Equipment Source Type: news
FDA approves expanded indication for medical device to treat a form of brain cancer
The U.S. Food and Drug Administration today approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy. (Source: Food and Drug Administration)
Source: Food and Drug Administration - October 5, 2015 Category: American Health Source Type: news
Cancer treatment outcomes are influenced by genetics and race, according to new study
A person's response to anticancer drug treatments is strongly related to their genetic ancestry, new research concludes. Notable associations were found for the drug temozolomide, which is used to treat brain tumors. Other drugs with results that suggest an association include etoposide and mitomycin, but the authors note that these results should be viewed as hypothesis generation. (Source: ScienceDaily Headlines)
Source: ScienceDaily Headlines - September 11, 2015 Category: Science Source Type: news
