Heavy! Novartis anticancer drug Farydak is approved by the FDA as the first HDAC inhibitor to treat multiple myeloma
February 26, 2015 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];February 25, 2015 / Bio Valley BIOON / -- Swiss pharmaceutical giant Novartis has recently received heavy news, and Farydak (panobinostat, LBH589), a new anti-cancer drug that has experienced ups and downs, has finally gained FDA favor. The FDA has approved Faridak in combination with Velcade (bortezomib, bortezomib) and dexamethasone (dexamethasone) for multiple myeloma that has previously failed to treat at least two treatment regimens, including Velcade and an immunomodulatory (IMiD) drug ( Myltiple myeloma, MM) patient population. The FDA approves Farydak with a Risk Assessment and Mitigation Strategy (REMS) to educate and educate health professionals about the risks that may be associated with Farydak treatment. The approval also marks Faryda as the first histone deacetylase (HDAC) inhibitor for the treatment of multiple myeloma (MM), whose epigenetic activity may help restore multiple bone marrow The function of tumor cells. Currently, Farydak's regulatory review in other parts of the world is ongoing.
Farydak (panobinostat) is a novel, broad-spectrum histone deacetylase (HDAC) inhibitor with a novel mechanism of action that blocks cancer by blocking histone deacetylase (HDAC) Severe stress is applied until it dies, while healthy cells are unaffected.
Farydak is approved by the FDA's accelerated approval process. The drug was approved based on efficacy and safety data from a pre-defined subgroup analysis (n=193) in a global phase III clinical study (PANORAMA-1). Data show that in a multiple myeloma (MM) population previously treated with bortezomib and an immunomodulatory (IMiD) drug, combined with a standard treatment regimen (bortezomib + dexamethasone), with placebo ( Compared with PFS = 5.8 months, n = 99), Farydak extended median progression-free survival (PFS = 10.6 months, n = 94). In addition, 59% of patients in the Farydak treatment group had tumor shrinkage or disappearance after treatment, compared with 41% in the placebo group.
However, it is worth mentioning that Farydak's regulatory path can be described as a twist. At the beginning of 2014, when Novartis submitted a panobinostat regulatory application, the FDA said it would use the rapid approval channel to review the drug, reducing the review cycle from the usual 12 months to 8 months. However, at the end of November last year, the FDA Oncology Drug Advisory Committee (ODAC) recommended a refusal to approve panobinostat with a 5:2 vote. The committee said that panobinostat is indeed effective against a group of patients with multiple myeloma (MM), but the side effects of the drug are too serious and require careful consideration by the FDA. This proposal also forced the FDA to postpone the deadline set in December until March of this year. Afterwards, Novartis submitted additional analytical data and modified the panobinostat indication for multiple myeloma (MM) populations that had previously received at least 2 standard therapies including bortezomib and immunomodulators. After careful review by the FDA, panobinostat was finally approved. It should be noted that Farydak has a black box warning indicating severe diarrhea and severe and fatal cardiac events, arrhythmias, and electrocardiogram (ECG) changes.
Multiple myeloma (MM) is a blood cancer that is incurable and has a high recurrence rate. In the past 11 years, Takeda's anticancer drug Velcade (bortezomib) has been the only drug that has been proven to delay the overall survival and recurrent multiple myeloma (MM) survival. The clinical treatment of multiple myeloma (MM) plays an important role. However, there is still a huge medical need that is far from being met in this field.
Medical Face Mask,Splash Resistant Goggles,Medical Isolation Eye Goggles,Splash Proof Isolation Face Shield
GUANGDONG JIANGMEN RONGHAI MEDICAL TECHNOLOGY CO.,LTD , https://www.kimaomedical.com