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Epizyme Gets FDA Nod for Tazverik sNDA in Follicular Lymphoma

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Epizyme Inc. (EPZM - Free Report) announced that the FDA has approved the supplemental new drug application (sNDA) for lead drug,Tazverik (tazemetostat), for two distinct follicular lymphoma (FL) indications. The indications include adult patients with relapsed or refractory FL whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved test, and who have received at least two prior systemic therapies. The approval also includes adult patients with relapsed or refractory FL, who have no satisfactory alternative treatment option.

FL is a cancer that involves certain types of white blood cells known as lymphocytes. 

These indications were approved under accelerated approval, with a priority review based on overall response rate and duration of response in the company’s phase II study cohorts of FL patients with EZH2 mutations and wild-type EZH2.

Epizyme’s stock has declined 16.8% year to date against the industry’s growth of 9.2%.

The approval of Tazverikto treat the two FL indications will lead to increased sales for the company.

In January, the FDA granted accelerated approval to Tazverik 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 for ES 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.

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 - Free Report) and Roche (RHHBY - Free Report) , among others.

Epizyme, Inc. Price

 

Epizyme, Inc. Price

 

Epizyme, Inc. price | Epizyme, Inc. Quote

Zacks Rank & Another Stock to Consider

Epizyme currently carries a Zacks Rank #1 (Strong Buy).

Another similar-ranked stock in the biotech sector is Akcea Therapeutics Inc. . You can see the complete list of today’s Zacks #1 Rank stocks here.

Akcea’s loss per share estimates have narrowed from $2.07 to $1.37 for 2020 and from $2.46 to $1.85 for 2021 in the past 60 days.

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