Zydelig

Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, B-Cell Lymphomas

Treatment

5 FDA approvals

2 Active Studies for Zydelig

What is Zydelig

Idelalisib

The Generic name of this drug

Treatment Summary

Idelalisib is a medication used to treat chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). It works by targeting an enzyme called phosphatidylinositol-4,5-bisphosphate 3-kinase (PI-3K) that is involved in cell growth, proliferation, and survival. By inhibiting this enzyme, idelalisib can induce the death of cancer cells and block certain cell signaling pathways that are involved in the movement of B-cells

Zydelig

is the brand name

image of different drug pills on a surface

Zydelig Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Zydelig

Idelalisib

2014

2

Approved as Treatment by the FDA

Idelalisib, also known as Zydelig, is approved by the FDA for 5 uses which include Leukemia, Lymphocytic, Chronic, B-Cell and relapsed Small Lymphocytic Lymphoma .

Leukemia, Lymphocytic, Chronic, B-Cell

Used to treat Relapsed Chronic Lymphocytic Leukemia in combination with Rituximab

relapsed Small Lymphocytic Lymphoma

relapsed follicular B-cell non-Hodgkin's lymphoma

B-Cell Lymphomas

Chronic Lymphocytic Leukemia

Effectiveness

How Zydelig works in the body

Idelalisib works by blocking a certain enzyme, P110δ. This enzyme is found in white blood cells and helps them to grow, move, and survive. By blocking P110δ, idelalisib causes cancer cells to die and stops certain cell signals that help the movement and settling of B-cells in the lymph nodes and bone marrow. This medication has also been shown to stop the movement and sticking of cancer cells, reducing their ability to survive.

When to interrupt dosage

The proposed amount of Zydelig is contingent upon the specified condition, such as B-Cell Lymphomas, Chronic Lymphocytic Leukemia and Relapsed Chronic Lymphocytic Leukemia. The dosage is dependent on the administration technique featured in the table below.

Condition

Dosage

Administration

Chronic Lymphocytic Leukemia

100.0 mg, 150.0 mg,

, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Leukemia, Lymphocytic, Chronic, B-Cell

100.0 mg, 150.0 mg,

, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

B-Cell Lymphomas

100.0 mg, 150.0 mg,

, Oral, Tablet, Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Warnings

Zydelig Contraindications

Condition

Risk Level

Notes

Toxic Epidermal Necrolysis

Do Not Combine

anaphylaxis

Do Not Combine

There are 20 known major drug interactions with Zydelig.

Common Zydelig 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 Idelalisib is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.

Acteoside

Major

The risk or severity of adverse effects can be increased when Idelalisib is combined with Acteoside.

Antilymphocyte immunoglobulin (horse)

Major

The risk or severity of adverse effects can be increased when Idelalisib is combined with Antilymphocyte immunoglobulin (horse).

Bacillus calmette-guerin substrain russian BCG-I live antigen

Major

The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Idelalisib.

Baricitinib

Major

The risk or severity of adverse effects can be increased when Idelalisib is combined with Baricitinib.

image of a doctor in a lab doing drug, clinical research

Zydelig Novel Uses: Which Conditions Have a Clinical Trial Featuring Zydelig?

At present, 7 clinical trials are underway to determine the potential of Zydelig in treating B-Cell Lymphomas, Chronic Lymphocytic Leukemia and Relapsed Chronic Lymphocytic Leukemia.

Condition

Clinical Trials

Trial Phases

B-Cell Lymphomas

0 Actively Recruiting

Chronic Lymphocytic Leukemia

0 Actively Recruiting

Leukemia, Lymphocytic, Chronic, B-Cell

2 Actively Recruiting

Phase 1

Zydelig Reviews: What are patients saying about Zydelig?

5

Patient Review

8/2/2016

Zydelig for Relapsed Follicular B-Cell Non-Hodgkin Lymphoma

Zydelig has given me 13 months of remission after years of grueling chemotherapy and a stem cell transplant relapse. I've had no side effects and am finally enjoying a good quality of life!
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about zydelig

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

How long do you take Zydelig?

"The rituximab treatment cycle lasts for 28 days (4 weeks) and you usually have a total of 8 doses. The idelalisib tablets are taken twice a day and the treatment can last for up to 6 cycles. You continue idelalisib for as long as it is working and the side effects aren't bad."

Answered by AI

How is Zydelig administered?

"The recommended dosage of Zydelig is 150 mg twice daily, oral, with or without food, until disease progression or toxicity becomes unacceptable."

Answered by AI

What kind of drug is idelalisib?

"Idelalisib is a cancer medication that works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells."

Answered by AI

Who makes Zydelig?

"The U.S. Food and Drug Administration (FDA) today approved Zydelig® (idemalisib), a kinase inhibitor, for two indications: in combination with rituximab for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least two prior therapies, and as a single-agent therapy for the treatment of patients with relapsed/refractory small lymphocytic lymphoma (SLL).

The FDA has approved Gilead Sciences' Zydelig for the treatment of two types of blood cancer - follicular lymphoma and small lymphocytic lymphoma. The drug is approved for use in combination with rituximab for the treatment of patients with relapsed/refractory follicular lymphoma who have received at least two prior therapies. It is also approved as a single-agent therapy for the treatment of patients with relapsed/refractory small lymphocytic lymphoma."

Answered by AI

Is Zydelig a chemotherapy?

"Targeted therapies are a type of cancer treatment that uses drugs or other substances to more precisely identify and attack cancer cells while doing little damage to normal cells.

The drug Zydelig®, also known by its generic name idelalisib, is a type of targeted cancer therapy. This means that it is designed to specifically target cancer cells while doing little damage to normal, healthy cells."

Answered by AI

What is Zydelig used for?

"This drug is used to treat certain types of cancer, such as chronic lymphocytic leukemia-CLL, follicular B-cell non-Hodgkin's lymphoma, and small lymphocytic lymphoma-SLL. Idelalisib is a type of drug called a kinase inhibitor, which works by slowing or stopping the growth of cancer cells."

Answered by AI

Clinical Trials for Zydelig

Image of Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute in Cleveland, United States.

BAFF CAR-T Cells for Chronic Lymphocytic Leukemia

18+
All Sexes
Cleveland, OH

CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function. BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.

Phase 1
Recruiting

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Paolo Caimi, MD

Image of Houston Methodist Hospital in Houston, United States.

CD19.CAR-aNKT Cells for Lymphoma and Leukemia

3 - 75
All Sexes
Houston, TX

This study is for patients who have lymphoma or leukemia that has come back or has not gone away after treatment. Because there is no standard treatment for this cancer, patients are being asked to volunteer for a gene transfer research study using special immune cells. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and immune cells. Antibodies are types of proteins that protect the body from bacteria and other diseases. Immune cells, also called lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and lymphocytes have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the NKT cells, a special type of lymphocytes that can kill tumor cells but not very effectively on their own. When an antibody is joined to a T cell in this way it is called a chimeric receptor. Investigators have also found that NKT cells work better if proteins are added that stimulate lymphocytes, such as one called CD28. Adding the CD28 makes the cells last for a longer time in the body but maybe not long enough for them to be able to kill the lymphoma cells. It is believed that by adding an extra stimulating protein, called IL-15, the cells will have an even better chance of killing the lymphoma cells. In this study the investigators are going to see if this is true by putting the anti-CD19 chimeric receptor with CD28 and the IL-15 into NKT cells grown from a healthy individual. These cells are called ANCHOR cells. These cells will be infused into patients that have lymphomas or leukemias that have CD19 on their surface. The ANCHOR cells are investigational products not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of ANCHOR cells that is safe, to see how long the ANCHOR cells last, to learn what their side effects are and to see whether this therapy might help people with lymphoma or leukemia.

Phase 1
Waitlist Available

Houston Methodist Hospital (+1 Sites)

Carlos Ramos, MD