Please ensure Javascript is enabled for purposes of website accessibility

Epizyme's Tazverik Wins FDA Approval to Treat Follicular Lymphoma

By Todd Campbell – Jun 18, 2020 at 4:57PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The label expansion for the drug significantly increases the number of patients to whom it can be prescribed.

Epizyme (EPZM) on Thursday announced that had it secured Food and Drug Administration approval for the drug Tazverik to be used in previously treated adults with follicular lymphoma and an EZH2 mutation, and in relapsed or refractory patients with no other treatment options. Back in January, the regulator approved Tazverik as a treatment for metastatic or locally advanced epithelioid sarcoma patients who aren't eligible for surgery.

An FDA approval stamp on a desk next to a blister pack of pills.

IMAGE SOURCE: GETTY IMAGES.

The oral medicine can reduce cancer cell growth by blocking the activity of the EZH2 enzyme. An incurable disease, follicular lymphoma develops in the white blood cells, lymphatic system, and bone marrow. It accounts for about 25% of non-Hodgkin lymphoma cases, and about 2.5 cases of it are diagnosed for every 100,000 people every year, according to the National Cancer Institute.

In clinical trials, follicular lymphoma patients with the EZH2 activating mutation who had previously received two or more therapies had an overall response rate of 69% to Tazverik, including 12% who achieved a complete response. In patients with wild-type EZH2, the overall response rate was 34%, including 4% who achieved a complete response.

Tazverik's label expansion is significant for the biotech company because far more patients are diagnosed with follicular lymphoma than epithelioid sarcoma, a soft-tissue cancer with an incidence rate of only 0.4 cases per million people. In the first quarter, Epizyme reported net sales of $1.3 million for Tazverik following its launch on Feb. 1.

In hope of earning further label expansions for Tazverik, Epizyme is also evaluating it in combination with doxorubicin as a first-line ES treatment, and is conducting a confirmatory trial of it in combination with Revlimid and Rituxan as a second-line follicular lymphoma treatment. A trial is also underway testing it in chemotherapy-naive metastatic castration-resistant prostate cancer patients alongside the blockbuster drugs Xtandi and Zytiga.

Todd Campbell has no position in any of the stocks mentioned. His clients may have positions in the companies mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Epizyme Stock Quote
Epizyme
EPZM

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
332%
 
S&P 500 Returns
104%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 09/30/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.