Tazverik (tazemetostat) is the first treatment approved for the treatment of metastatic or locally advanced epithelioid sarcoma in patients aged 16 years and older.
Epizyme submitted a new drug application (NDA) for tazemetostat to the US Food and Drug Administration (FDA) in May 2019, with Priority Review status granted in July 2019. The drug received accelerated approval from the FDA in January 2020.
The company has worldwide development and commercialisation rights for tazemetostat, except Japan, where they are held by Eisai. Both companies hold licenses for royalties on sales outside their region.
Royalty Pharma agreed with Eisai to purchase its rights to receive royalties on the future global sales of the drug in November 2019. Epizyme selected Onco360 Oncology Pharmacy as the exclusive speciality pharmacy partner for the marketing of Tazverik.
Tazverik also received orphan drug designation. It is available as oral, twice daily film-coated, red, round, biconvex shaped tablets in 200mg strength.
Epithelioid sarcoma is a rare, slow-growing soft tissue cancer, accounting for less than 1% of all the soft tissue cancers. It originates as a painless small lump in the soft tissue of the hand, lower leg or forearm and can spread to other parts of the body and is more common in men and young adults.
The disease is difficult to diagnose, with a high recurrence rate. With the growth of the tumour, one can experience swelling and pain, if it presses on any nerve or muscle. Approximately 13,000 people are diagnosed with the disease annually, causing 5,100 deaths.
The small molecule tazemetostat inhibits EZH2 methyltransferase activity, which is highly expressed in the sarcoma cells and plays a crucial role in cancer initiation and growth.
More than 90% of patients with epithelioid sarcoma have a genetic mutation called loss of INI-1 gene function, which makes the patient responsive to tazemetostat.
FDA approval of tazemetostat comes from Phase II, open-label, single-arm, multi-centre clinical study, EZH-202 in advanced epithelioid sarcoma patients. A total of 250 patients enrolled in the clinical study; 62 patients in Cohort 5 received 800mg Tazverik twice daily until disease headway or increase in toxicity to an unacceptable level.
The primary goal of the study was to evaluate the overall response rate and duration of response in patients every eight weeks.
The overall response rate of the drug was 15%, which included 1.6% of patients who demonstrated complete response and 13% of patients who showed partial response. The response lasted for six months or longer in approximately 67% of patients. The treatment was well-tolerated with clinically significant and durable responses in patients.
Common adverse effects of the drug observed in patients during the study were pain, nausea, fatigue, vomiting, loss of appetite and constipation.
The company plans to conduct a global confirmatory study to support complete approval of the drug.
Tazemostat is being evaluated in multiple clinical studies as single-agent therapy including Phase II clinical trials for relapsed or refractory non-Hodgkin lymphoma (NHL) in patients with specified genetically defined solid tumours, assessed in paediatric patients for tumours such as synovial sarcoma and INI1-negative tumours.
Tazemostat, in combination with R-CHOP, a chemotherapy combo, is being studied for the first-line treatment of diffuse large B-cell lymphoma (DLBCL) in patients with high risk. Tazemetostat, in combination with Tecentriq™ (atezolizumab), is being evaluated to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Epizyme is a clinical-stage biopharmaceutical company engaged in the development of novel epigenetic therapies for cancer and other deadly diseases.
In addition to tazemetostat, the company has three new drug candidates and a set of preclinical candidates in its pipeline.
Headquartered in Cambridge, US, Epizyme has more than 120 full-time employees.
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