Beleodaq (belinostat) Cost, Dosage, Side Effects, and Prescribing Information for Lymphoma | Arti Sharma, PharmD | RxEconsult

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Beleodaq (belinostat) Cost, Dosage, Side Effects, and Prescribing Information Category: Hematology by - July 15, 2014 | Views: 30808 | Likes: 0 | Comment: 0  

Beleodaq (belinostat) for Lymphoma

Brand Name: Beleodaq
Generic Name: belinostat

Drug Class: Histone deacetylase inhibitor
Similar Drugs:  Folotyn (pralatrexate), Istodax (romidespsin)
Manufacturer: Spectrum Pharmaceuticals, Inc.
FDA Approval Date: July 3, 2014

What is Beleodaq and how does it work?

Beleodaq (belinostat) is a prescription cancer treatment.  It is approved to treat patients who are suffering from relapsed or refractory peripheral T-cell lymphoma (PTCL). These patients have PTCL which is hard to treat and have experienced return of their cancer after treatment with other anti-cancer medications or have failed to respond to previous therapy.

Beleodaq belongs to class of medications known as histone deacetylase inhibitors. Histone deacetylase is a major enzyme involved in blocking the activity of tumor suppressor genes. Increased activity of histone deacetylase in cancer cells promotes their growth and spread. By blocking histone deacetylase enzymes, Beleodaq stops cancer growth and causes death in existing cancer cells.  Furthermore, laboratory studies have shown that Beleodaq is preferentially toxic to cancer cells compared to normal cells.

What is the indication for Beleodaq?

Beleodaq is used to treat a rare type of lymphoma (blood cancer). People with lymphoma have uncontrolled growth of lymphocytes (white blood cells). There are two main types of lymphocytes, B cells and T cells. Beleodaq is used to treat peripheral T-cell lymphoma (PTCL), a type of non-Hodgkin lymphoma. This type of cancer is fast growing and primarily affects the lymph nodes. The human body has hundreds of lymph nodes and their main function is to filter and remove harmful substances from the body. Lymph nodes contain high concentrations of T cells and therefore serve as ideal reservoirs of this particular type of cancer. Beleodaq can be used to treat PTCL in patients who have failed treatment with other anti-cancer agents. 

How effective is Beleodaq?

Beleodaq was approved by the US Food and Drug Administration (FDA) through the agency’s accelerated approval program based on tumor response rate and duration of response to Beleodaq. This program allows the early approval of drugs based on benefits seen with intermediate endpoints. This approach is usually reserved for drugs that are used to treat serious or rare medical conditions. Medications approved through the accelerated program must be clinically beneficial in confirmatory trials.

The effectiveness of Beleodaq was evaluated in an open label, single-arm, non-randomized international clinical trial at 62 treatment locations.  A total of 129 patients suffering from relapsed or refractory PTCL were treated with Beleodaq. Patients were given 1,000 mg/m2 of Beleodaq over 30 minutes via intravenous infusion (IV) once daily on days 1-5 of a 21 day cycle. Treatment was repeated every 3 weeks until cancer progression or occurrence of unacceptable side effects. The primary endpoint of treatment efficacy was response rate. Response rate included complete and partial response and was evaluated by an independent review committee. Complete response referred to the disappearance of the cancer while partial response referred to tumor shrinkage. The response rate was assessed with use of the International Workshop Criteria (IWC). Overall, 25.8% of the 129 patients treated were able to achieve either completed or partial response with Beleodaq treatment. 

Additionally, the main secondary efficacy endpoint was the measured duration of treatment response. The duration of response measured time between the first day of response to either worsening of the cancer or death. The reported median duration of response was 8.4 weeks. The median time to response in all responders was 5.6 weeks with a range of 4.3 to 50.4 weeks.


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