Farydak

Multiple Myeloma
Treatment
2 FDA approvals
6 Active Studies for Farydak

What is Farydak

PanobinostatThe Generic name of this drug
Treatment SummaryPanobinostat is a medication used to treat multiple myeloma, a cancer of the bone marrow, and is sold under the brand name Farydak. This treatment works by blocking an enzyme that is involved in regulating gene expression. It is approved by the FDA, although additional clinical trials are still in progress to confirm its efficacy. Panobinostat is the most powerful histone deacetylase inhibitor available.
Farydakis the brand name
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Farydak Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Farydak
Panobinostat
2015
6

Approved as Treatment by the FDA

Panobinostat, also called Farydak, is approved by the FDA for 2 uses such as Refractory Multiple Myeloma and Multiple Myeloma .
Refractory Multiple Myeloma
Used to treat Refractory Multiple Myeloma in combination with Bortezomib
Multiple Myeloma
Used to treat Refractory Multiple Myeloma in combination with Bortezomib

Effectiveness

How Farydak works in the bodyPanobinostat is a drug that helps fight multiple myeloma. It does this by inhibiting a group of proteins called deacetylase or histone deacetylase proteins, which are responsible for regulating how other proteins work. Panobinostat prevents these proteins from doing their job, which has the effect of altering gene expression and inhibiting protein metabolism. It also works in combination with another drug called bortezomib to make the treatment of multiple myeloma more effective.

When to interrupt dosage

The suggested dose of Farydak is contingent upon the recognized affliction. The amount of dosage shifts as per the approach of delivery (e.g. Capsule - Oral or Oral) featured in the table beneath.
Condition
Dosage
Administration
Multiple Myeloma
, 10.0 mg, 15.0 mg, 20.0 mg
, Oral, Capsule, Capsule - Oral

Warnings

There are 20 known major drug interactions with Farydak.
Common Farydak Drug Interactions
Drug Name
Risk Level
Description
9-(N-methyl-L-isoleucine)-cyclosporin A
Major
The risk or severity of adverse effects can be increased when Panobinostat is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
Abetimus
Major
The risk or severity of adverse effects can be increased when Panobinostat is combined with Abetimus.
Acteoside
Major
The risk or severity of adverse effects can be increased when Panobinostat is combined with Acteoside.
Anagrelide
Major
The risk or severity of QTc prolongation can be increased when Panobinostat is combined with Anagrelide.
Antilymphocyte immunoglobulin (horse)
Major
The risk or severity of adverse effects can be increased when Panobinostat is combined with Antilymphocyte immunoglobulin (horse).
Farydak Toxicity & Overdose RiskFarydak has a warning label that alerts patients and healthcare professionals to the possibility of severe diarrhea and dangerous heart conditions, such as irregular heartbeat and changes in the electrical signals of the heart. To reduce the risk of these side effects, Farydak is accompanied by a Risk Evaluation and Mitigation Strategy (REMS) which includes information about the risks and how to minimize them.
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Farydak Novel Uses: Which Conditions Have a Clinical Trial Featuring Farydak?

17 active clinical trials are currently underway to assess the efficacy of Farydak in treating Refractory Multiple Myeloma.
Condition
Clinical Trials
Trial Phases
Multiple Myeloma
6 Actively Recruiting
Phase 2, Phase 1, Not Applicable

Farydak Reviews: What are patients saying about Farydak?

1Patient Review
5/11/2017
Farydak for Multiple Myeloma
DO NOT USE!!! This will damage your liver! My mom was healthy before she took this for one week, and now we're bury her two weeks later.
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Patient Q&A Section about farydak

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Farydak discontinued?

"On November 30, 2021, Secura Bio announced the withdrawal of Farydak. The required post-approval studies had not been completed and the clinical benefits of Farydak could not be confirmed at that time."

Answered by AI

What is Farydak used for?

"Farydak is a medication used to treat multiple myeloma. It is used in combination with bortezomib and dexamethasone, and is only indicated for use in patients who have received at least two prior treatments, including bortezomib and an immunomodulatory agent."

Answered by AI

Who manufactures Farydak?

"The Novartis Corporation has been given the go-ahead by the U.S. Food and Drug Administration to start selling Farydak, its new medication for treating patients with multiple myeloma. This is the first time that such a drug, known as an HDAC inhibitor, has been approved for use in the United States."

Answered by AI

Why was Farydak withdrawn?

"The company has decided to withdraw its application because it is not able to finish the clinical studies that were required for the accelerated approval process. Therefore, it has not been able to confirm the clinical benefits of Farydak."

Answered by AI

Clinical Trials for Farydak

Image of Washington University School of Medicine in St Louis, United States.

NT-I7 + CAR-T Therapy for Multiple Myeloma

18+
All Sexes
St Louis, MO
CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown. This is a two-arm, double blind, placebo-controlled, randomized, single-site phase Ib study testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (Cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.
Phase 1
Waitlist Available
Washington University School of MedicineMichael Slade, M.D., M.S.C.INeoImmuneTech
Image of Duke University Health System in Durham, United States.

Selinexor + Antibody for Multiple Myeloma

18+
All Sexes
Durham, NC
The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy. The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken. Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
Phase 2
Recruiting
Duke University Health SystemYubin Kang, MD
Image of University Hospitals Cleveland Medical Center Seidman Cancer Center in Cleveland, United States.

CAR T-cell Therapy for Multiple Myeloma

18+
All Sexes
Cleveland, OH
The purpose of this study is to determine if UF-KURE-BCMA (B-Cell Maturation Antigen) chimeric antigen receptor T cells (CAR-T cells) can be used to treat relapsed or treatment refractory multiple myeloma (RRMM). This treatment uses T cells already present within the body that have been modified outside of the body by a virus and then returned by an infusion to fight cancer. The investigators are evaluating UF-KURE-BCMA because it uses a manufacturing process that is shorter than other Food and Drug Administration (FDA) approved CAR-T cells and only requires a simple blood draw. The standard treatments require weeks to manufacture the cells as well a special procedure to get an individual's cells. While the shorter manufacture time can be an advantage, the safety of this approach has not been demonstrated. The use of UF-KURE-BMCA is investigational and is not approved by the FDA outside of clinical trials. This is the first study of UF-KURE-BCMA in patients. Participants will give a pint of blood, which is the amount one would provide if they were to donate blood. The blood will be used to make the UF-KURE-BCMA cells. Participants will then receive chemotherapy followed by a one-time infusion of the experimental modified CAR-T cells. After this infusion, participants will be watched for side effects and follow up will continue for up to 15 years.
Phase 1
Waitlist Available
University Hospitals Cleveland Medical Center Seidman Cancer CenterJames Ignatz-Hoover, MD, PhD
Image of Princess Margaret Cancer Centre in Toronto, Canada.

Early Palliative Care for Multiple Myeloma and Lymphoma

18+
All Sexes
Toronto, Canada
Patients with multiple myeloma experience a wide range of physical and psychological symptoms from the time of their diagnosis. Meanwhile, patients with aggressive lymphomas undergo unpredictable illness courses, resulting in goals of care conversations occurring late in the illness trajectory and aggressive care being received in the last 30 days of life. Early palliative care alongside usual cancer care has been shown to improve patient outcomes such as symptom burden, mood, and quality of life in patients with solid tumours (e.g. lung, breast or gynecological cancers), but has not been explored among patients with blood cancers to date. The goal of this clinical trial is to a brief early palliative care intervention for patients with multiple myeloma and aggressive B cell lymphoma attending the Princess Margaret Cancer Centre. The main goals of the study are: * To see if it is possible to apply the early palliative care intervention for patients with multiple myeloma and aggressive lymphoma * To see if this early palliative care intervention works well for these patients * To compare patient experiences with early palliative care and usual care. Participants will be randomly assigned to one of two groups: one group will receive early palliative care in addition to usual care from their blood cancer doctor, and the other group will receive usual care from their blood cancer doctor only. All participants will be asked to fill out questionnaires about their symptom burden, mood, quality of life, and satisfaction with care throughout the study. Some participants will also be asked to take part in interviews at the end of the trial to answer questions about their experience taking part in the study. Researchers will compare the results between the two groups to see if there are any improvements in quality of life for the patients who received early palliative care. The researchers will use the results of this study to guide in the development of a larger clinical trial.
Recruiting
Has No Placebo
Princess Margaret Cancer CentreBreffni Hannon, MD
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