Epizyme, Inc. EPZM announced that the FDA has granted accelerated approval to lead drug Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years or older with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for complete resection.
Tazverik is a methyltransferase inhibitor. The approval was based on the overall response rate and the duration of response in a phase II study.
Per the company, Tazverik is now the first and only FDA-approved EZH2 inhibitor as well as a treatment specifically indicated for ES patients.
An approval was in the cards as the Oncologic Drugs Advisory Committee (ODAC) of the FDA had voted (11-0) in favor of the benefit-risk profile of the drug for the above-mentioned indication in December.
The continued approval of Tazverik for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial. Epziyme’s ongoing, global, randomized, controlled confirmatory trial assessing the combination of Tazverik and doxorubicin compared with doxorubicin plus placebo as a front-line treatment for ES is underway.
Moreover, Epizyme will conduct certain post-marketing activities which include clinical pharmacology evaluations to evaluate the effect of Tazverik on liver function and the effect of CYP3A inhibitors and inducers on the drug to inform aspects of the prescribing information. It will also expand enrollment in cohort 6 of the phase II study to at least 60 ES patients. This expansion is intended to provide more patient experience for potential future inclusion in the label.
The approval will significantly boost Epizyme’s portfolio, which did not have any approved drug in its kitty till now.
Epizyme’s stock has soared 176.6% in the past year against the industry’s decline of 3.1%.
Meanwhile, the company is also exploring tazemetostat in investigational clinical studies in other solid tumors and hematological malignancies, as monotherapy and combination therapy in both relapsed and front-line disease settings.
The company also submitted a New Drug Application (NDA) to the FDA for accelerated approval of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma (FL), both with or without EZH2 activating mutations, who have received at least two prior lines of systemic therapy.
Further, the company is exploring additional molecules in its novel G9a inhibitor program. Since Epizyme has limited sources for drug development, it inked collaborations with bigwigs like GlaxoSmithKline GSK and Roche RHHBY, among others.
Zacks Rank & Another Stock to Consider
Epizyme currently carries a Zacks Rank #1 (Strong Buy). Another similar-ranked stock in the sector is Alexion ALXN. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alexion’s earnings per share estimates have increased from $10.36 to $10.42 for 2019 and from $11.10 to $11.32 for 2020 in the past 90 days.
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