Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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.”

…

“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.

New Developments in Lymphoma–Newsletter

The Lymphoma Program has published the inaugural issue of the New Developments in Lymphoma Newsletter.

Please look to this space for further announcements of future newsletter issues, or sign up for advance notice of the newsletter here.