Epizyme hits the ground running with second — and crucial — OK for Tazverik, in follicular lymphoma
When Epizyme scored the first-ever approval for tazemetostat, in epithelioid sarcoma, execs made it clear it was only an appetizer, something to whet the appetites of regulators, investors and physicians to the potential of the methyltransferase inhibitor. Five months later, they are ready to serve the main course.
The biotech got all the help from the FDA to expand the label for Tazverik, going through priority review to land an accelerated approval in two indications of follicular lymphoma:
- 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
- Adult patients with relapsed or refractory FL who have no satisfactory alternative treatment options
The OK was anchored on overall response rate and duration of response in a Phase II, which encompassed both mutated and wild-type EZH2.
“As a reminder, in the EZH2 MT cohort, the response rate was 69%, while in the EZH2 WT cohort, the response rate was roughly half, at 35%,” SVB Leerink analyst Andrew Berens wrote at the news of the priority review. “While we think that the benefit in the wild-type patients is still compelling enough for some patients to consider therapy, it is less compelling than that seen in the EZH2m cohort.”
That could mean that in practice, clinicians will want a EZH2 test before prescribing the drug, reducing the significance of the broad label.
As such, he models $17.5 million in FL sales and $5.6 million of ES sales for 2020.
CMO Shefali Agarwal, though, is clearly pleased with what they achieved with the “very efficient” NDA, leveraging data that have already been submitted with the ES package. Especially considering that FL, a subtype of non-Hodgkin lymphoma that accounts for 20% to 30% of cases, is often considered a chronic disease.
“In our view, there remains no clear standard of care in the relapsed and/or refractory FL population as not all patients benefit from today’s available therapies,” she said in a statement. “Based on this label, physicians will have the ability to use their clinical discretion to prescribe TAZVERIK for their relapsed or refractory patients regardless of EZH2 mutational status and without regard to a specific line of treatment where other options are not satisfactory.”
CEO Robert Bazemore added that Epizyme has already “seamlessly” expanded the commercial team, armed with what they believe is a notable safety profile and compelling option for oral, at-home administration.
A full approval will hinge upon a 500-patient confirmatory trial Epizyme is conducting that pairs Tazverik with Revlimid and rituximab (Rituxan) for FL patients in the second or later lines.