Tag: lymphoma treatment

Zydelig Approved by FDA for Patients with CLL, FL, & SLL

Earlier this afternoon the FDA announced the approval of Zydelig (idelalisib) for patients with relapsed chronic lymphocytic leukemia (CLL). Accelerated approval was also granted for the use of  Zydelig in patients with relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL). According to the FDA press release:

“Zydelig’s safety and effectiveness to treat relapsed CLL were established in a clinical trial of 220 participants who were randomly assigned to receive Zydelig and Rituxan or placebo and Rituxan. The trial was stopped for efficacy following the first pre-specified interim analysis point, which showed participants treated with Zydelig and Rituxan lived 10.7 months without their disease progressing (progression-free survival) compared to about 5.5 months for participants treated with placebo and Rituxan. Results from a second interim analysis continued to show a statistically significant improvement for Zydelig and Rituxan over placebo and Rituxan.”

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“Zydelig’s safety and effectiveness to treat relapsed FL and relapsed SLL were established in a clinical trial with 123 participants with slow-growing (indolent) non-Hodgkin lymphomas. All participants were treated with Zydelig and were evaluated for complete or partial disappearance of their cancer after treatment (objective response rate, or ORR). Results showed 54 percent of participants with relapsed FL and 58 percent of participants with SLL experienced ORR.”

Commenting on this welcomed development Dr. Richard Furman said, “We are very excited to have idelalisib to add to our armentarium of agents that are now available for use and would like to thank all of the patients and their families who made this possible by participating in the clinical trials.” Look to this blog and our clinical trials page for further developments regarding the use of Zydelig in the treatment of CLL, FL, & SLL patients.

FDA Announces Approval for Beleodaq in Treatment of Peripheral T-cell Lymphoma

Earlier today the US FDA announced the approval of Beleodaq (belinostat) for the treatment of non-Hodgkin lymphoma patients with relapsed or refractory peripheral T-cell lymphoma.  Beleodaq has previously received the FDA orphan product designation due to its utility in treating this rare disease. Beleodaq functions by inhibiting the enzymes that contribute to T-cell growth. During clinical trials:

“The safety and effectiveness of Beleodaq was evaluated in a clinical study involving 129 participants with relapsed or refractory PTCL. All participants were treated with Beleodaq until their disease progressed or side effects became unacceptable. Results showed 25.8 percent of participants had their cancer disappear (complete response) or shrink (partial response) after treatment.”

“The most common side effects seen in Beleodaq-treated participants were nausea, fatigue, fever (pyrexia), low red blood cells (anemia), and vomiting.”

Look to this blog and our clinical trials page for further developments regarding the use of Beleodaq in the treatment of peripheral T-cell lymphoma.

Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

Yesterday, investigators announced the U.S. FDA  “Breakthrough Therapy Designation” approval for the investigational PD-1 immune checkpoint inhibitor nivolumab in the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. The FDA designation was created to expedite the development process of drugs aimed at treating serious and life-threatening conditions. These new  findings for nivolumab are based on an ongoing Phase 1b trial. Nivolumab also known as BMS-936558 or MDX1106 is an,

“…investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. We are investigating whether by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.”

Look to this blog and our clinical trials page for further developments regarding the use of nivolumab in the treatment of Hodgkin lymphoma.