TAZVERIK is indicated for the treatment of metastatic epithelioid sarcoma in patients who are not eligible for complete resection
FDA centre for drug evaluation and research. (Credit: The U.S. Food and Drug Administration/Wikipedia.)
Epizyme has obtained the US Food and Drug Administration (FDA) accelerated approval of TAZVERIK (tazemetostat) for metastatic epithelioid sarcoma (ES) in patients aged 16 years and older.
The biopharmaceutical firm said that the regulatory approval indicated TAZVERIK for the treatment of metastatic ES in patients who are not eligible for complete resection, based on overall response rate and duration of response in Phase 2 clinical trial.
Epizyme president and chief executive officer Robert Bazemore said: “Today’s accelerated approval of TAZVERIK is a landmark event for people with ES and represents our dedication to our mission of rewriting treatment for people with cancer and other serious diseases.
“TAZVERIK is now the first and only FDA-approved EZH2 inhibitor, and the first and only FDA-approved treatment specifically indicated for ES patients. Our commercial launch plans are underway, and we expect to make TAZVERIK available to ES patients and treating physicians across the U.S. within 10 business days.”
TAZVERIK is a methyltransferase inhibitor indicated for metastatic ES
Epizyme said that the further approval of the drug for the current indication is subject to the verification and description of clinical benefit in a confirmatory trial.
The company has already initiated a multi-national, randomized, controlled confirmatory trial to evaluate TAZVERIK in combination with doxorubicin versus doxorubicin combined with placebo as a treatment for ES.
In addition, Epizyme is expected to carry out clinical pharmacology evaluation to evaluate the effect of TAZVERIK on liver function and the effect of CYP3A inhibitors and inducers on TAZVERIK to determine the prescribing information.
The serious adverse reactions in patients using TAZVERIK include haemorrhage, pleural effusion, skin infection, dyspnea and pain, and the most common adverse events include pain, fatigue, nausea, decreased appetite, vomiting and constipation.
Epizyme’s Phase 2 trial investigator Gary K Schwartz said: “Despite industry advancements, there are limited therapeutic options for treating patients with epithelioid sarcoma who struggle with high rates of recurrence and toxicities associated with currently used therapies.
“The TAZVERIK data from the ES cohort in Epizyme’s Phase 2 trial support its potential to provide clinically meaningful and durable responses, and tolerability for ES patients. This approval of TAZVERIK represents an important advancement in the treatment of patients with ES.”