The U.S. Food and Drug Administration (FDA) on Monday approved Farydak (panobinostat) for the treatment of multiple myeloma (see related Beacon news).

Since the FDA announced its decision, multiple myeloma patients, care­givers, and health care professionals have been asking a number of important questions about Farydak. This article compiles many of those questions and provides answers to them.

The information in this article is based primarily on the official, FDA-approved prescribing information for Farydak. In addition, The Beacon has received feedback in regard to several questions …

Silver Spring, MD (Press Release) – On February 23, 2015, the U.S. Food and Drug Admin­istra­tion (FDA) granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharma­ceu­ticals) in com­bi­na­tion with bor­tez­o­mib and dexa­meth­a­sone for the treat­ment of patients with multiple myeloma who have received at least two prior regi­mens, in­­clud­ing bor­tez­o­mib and an immuno­modu­la­tory agent. As a con­di­tion of this accelerated approval, FDA requires the sponsor to conduct a trial to verify and describe the clin­i­cal benefit of panobinostat for patients with multiple myeloma.

Panobinostat is a histone deacetylase inhibitor.

The approval was …

The U.S. Food and Drug Administration (FDA) has approved panobinostat, which will be marketed under the brand name Farydak, for the treatment of relapsed and refractory multiple myeloma.

Specifically, Farydak has been approved for use in combination with Velcade (bortezomib) and dexamethasone (Decadron) in patients with multiple myeloma who have received at least two prior standard therapies.

The two prior therapies must include Velcade and at least one treatment from the immunomodulatory class of drugs, which includes Revlimid (lenalidomide), thalidomide, and Pomalyst (pomalidomide, Imnovid). …

• Farydak, an HDAC inhibitor with epigenetic activity, approved in combination for patients who received at least two prior regimens including bortezomib and IMiD[1]
• Farydak prolonged median PFS benefit when used with bortezomib and dexamethasone combination versus combination alone (from 6 to 11 months)[1]
• Multiple myeloma is an incurable blood cancer and there is an urgent need for new treatments[2]
• Farydak is approved under FDA's accelerated approval program; regulatory applications are underway in the EU, Japan

 …

Silver Spring, MD (Press Release) - The U.S. Food and Drug Admin­istra­tion today approved Farydak (panobinostat) for the treat­ment of patients with multiple myeloma.

Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow. According to the National Cancer Institute, approx­i­mately 21,700 Americans are diag­nosed with multiple myeloma and 10,710 die from the disease annually.

Primarily affecting older adults, multiple myeloma causes plasma cells to rapidly multiply and crowd out other healthy blood cells from the bone marrow. When …

The U.S. Food and Drug Administration (FDA) has postponed for up to three months its decision on pano­bino­stat’s new drug application.

The FDA action was announced earlier this morning in a press release issued by Novartis (NYSE:NVS), the Swiss pharmaceutical company developing pano­bino­stat as a potential new multiple myeloma therapy.

A decision on pano­bino­stat’s application for FDA approval had been expected by the end of this week. The decision was widely anticipated to be a negative one, given that earlier this month the FDA’s Oncologic Drugs Advisory Committee (ODAC) …

Basel, Switzerland (Press Release) - Novartis announced today that the US Food and Drug Admin­istra­tion (FDA) has extended their priority review period by up to three months for the new drug appli­ca­tion (NDA) of LBH589 (panobinostat) in com­bi­na­tion with bor­tez­o­mib* and dexa­meth­a­sone for patients with pre­vi­ously treated multiple myeloma.

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