Public health agency The US Food and Drug Administration Thursday awarded the accelerated approval for Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic epithelioid sarcoma based on the results of a clinical trial.
The FDA granted the approval of Tazverik to Epizyme Inc.
Epithelioid sarcoma is reportedly a rare sub-type of soft tissue sarcoma that often occurs in young adults.
Tazverik (tazemetostat) is approved for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet spread to distant parts of the body) epithelioid sarcoma not eligible for complete resection (surgically removing all of a tissue, structure, or organ).
Under the company's clinical trial, about 62 patients received 800mg of Tazverik twice a day until the disease progressed or the patient reached an unacceptable level of toxicity. The trial measured how many patients experienced complete or partial shrinkage of their tumors during treatment. The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response.
According to the agency, Tazverik blocks activity of the EZH2 methyltransferase, which may help keep the cancer cells from growing. Most cases of epithelioid sarcoma begin in the soft tissue under the skin of an extremity, though it can start in other areas of the body.
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
QST selects RayStation for advanced carbon ion therapy
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Innate Pharma reports preclinical efficacy of IPH45
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
enGene Holdings names new senior vice president, Urologic Oncology and Clinical Development
CLS secures second order from NIH Clinical Center for Thermal Therapy System accessories