Eisai wins an early FDA nod for its self-described cancer blockbuster

Eisai is counting on its new cancer drug to eventually bring in more than $1 billion a year, and now, thanks to an early FDA approval, the Japanese drugmaker has a head start on making that a reality.

The agency approved lenvatinib to treat the most common strain of thyroid cancer, a disease that kills nearly 2,000 Americans each year. The drug is a tyrosine kinase receptor inhibitor that blocks the growth agents tumors need to proliferate. And, in Phase III data released last year, the oral treatment significantly improved progression-free survival in thyroid cancer when compared to placebo.

FDA oncology chief Dr. Richard Pazdur

The drug, which will sell as Lenvima, won approval a full two months ahead of its already accelerated schedule, another affirmation of FDA oncology chief Dr. Richard Pazdur's willingness to hurry along so-called breakthrough treatments that could change the standard of care.

"The development of new therapies to assist patients with refractory disease is of high importance to the FDA," Pazdur said in a statement. "Today's approval gives patients and healthcare professionals a new therapy to help slow the progression of [differentiated thyroid cancer]."

As for Eisai, one of the company's execs told The Wall Street Journal this week that Lenvima has the potential to gross $1 billion a year by 2020 if everything goes according to plan. The thyroid approval is just step one in a process that includes ongoing trials in liver, kidney, lung and endometrial cancers. If the drug comes through on every indication, Eisai could well be sitting on an oncology blockbuster.

That would be welcome news for the beleaguered drugmaker. Thanks in part to recent patent expiries for Alzheimer's drug Aricept and acid reflux treatment AcipHex, Eisai's revenues are on the decline. And the company's latest launches, the weight-loss drug Belviq and seizure medication Fycompa, are facing exclusivity problems of their own.

- read the statement

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