FDA places partial hold on trials after secondary lymphoma

 

The drugmaker Epizyme has temporarily halted U.S.-based new-patient enrollment in clinical trials of the cancer drug tazemetostat after a pediatric patient developed a secondary T-cell lymphoma.

The Food and Drug Administration had issued a partial clinical hold in April on new enrollment of any patients with genetically defined solid tumors and hematologic malignancies. Patients already enrolled who have not had disease progression can continue to receive tazemetostat.

The hold was placed on all tazemetostat trials after a pediatric patient with advanced poorly differentiated chordoma developed a secondary T-cell lymphoma during a Phase 1 study. The patient had been on the study (NCT02601937) for about 15 months and had achieved a confirmed partial response at the time of the safety report. The patient has since discontinued the study drug and is being treated for lymphoma.

Tazemetostat is a first-in-class EZH2 inhibitor being studied as monotherapy in phase 1 and 2 trials for certain molecularly defined solid tumors, follicular lymphoma and diffuse large B-cell lymphoma, mesothelioma, and in combination studies of DLBCL and non–small cell lung cancer.

Epizyme is currently working to update informed consent, the investigator’s brochure, and study protocols, the company said in a statement.

[email protected]

 

The drugmaker Epizyme has temporarily halted U.S.-based new-patient enrollment in clinical trials of the cancer drug tazemetostat after a pediatric patient developed a secondary T-cell lymphoma.

The Food and Drug Administration had issued a partial clinical hold in April on new enrollment of any patients with genetically defined solid tumors and hematologic malignancies. Patients already enrolled who have not had disease progression can continue to receive tazemetostat.

The hold was placed on all tazemetostat trials after a pediatric patient with advanced poorly differentiated chordoma developed a secondary T-cell lymphoma during a Phase 1 study. The patient had been on the study (NCT02601937) for about 15 months and had achieved a confirmed partial response at the time of the safety report. The patient has since discontinued the study drug and is being treated for lymphoma.

Tazemetostat is a first-in-class EZH2 inhibitor being studied as monotherapy in phase 1 and 2 trials for certain molecularly defined solid tumors, follicular lymphoma and diffuse large B-cell lymphoma, mesothelioma, and in combination studies of DLBCL and non–small cell lung cancer.

Epizyme is currently working to update informed consent, the investigator’s brochure, and study protocols, the company said in a statement.

[email protected]

 

The drugmaker Epizyme has temporarily halted U.S.-based new-patient enrollment in clinical trials of the cancer drug tazemetostat after a pediatric patient developed a secondary T-cell lymphoma.

The Food and Drug Administration had issued a partial clinical hold in April on new enrollment of any patients with genetically defined solid tumors and hematologic malignancies. Patients already enrolled who have not had disease progression can continue to receive tazemetostat.

The hold was placed on all tazemetostat trials after a pediatric patient with advanced poorly differentiated chordoma developed a secondary T-cell lymphoma during a Phase 1 study. The patient had been on the study (NCT02601937) for about 15 months and had achieved a confirmed partial response at the time of the safety report. The patient has since discontinued the study drug and is being treated for lymphoma.

Tazemetostat is a first-in-class EZH2 inhibitor being studied as monotherapy in phase 1 and 2 trials for certain molecularly defined solid tumors, follicular lymphoma and diffuse large B-cell lymphoma, mesothelioma, and in combination studies of DLBCL and non–small cell lung cancer.

Epizyme is currently working to update informed consent, the investigator’s brochure, and study protocols, the company said in a statement.

[email protected]