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.
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Oscotec receives ODD from FDA for Cevidoplenib
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
TELA Bio launches LIQUIFIX for US hernia surgery
BD boosts US syringe production amid healthcare demand
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT
Upgraded Syngene International biologics facility to start operation in 2024
BioXcel Therapeutics secures European patent for method to treat agitation in dementia