Washington Editor

The FDA expanded Revlimid's label to include multiple myeloma with an approval that came out late Thursday.

Its maker, Celgene Corp., will market 15-mg and 25-mg capsules for the new indication, which specifies the drug's use in combination with the steroid dexamethasone for patients who have received at least one prior therapy. Therapy will begin at the higher dose, but can be reduced if needed.

"Hopefully, Revlimid will become the next step in changing the treatment paradigm of this disease and outlook for patients," Celgene CEO Sol Barer said in a conference call. Later, he noted that there is "no higher priority" for the Summit, N.J.-based company than launching the immunomodulatory agent for the new indication.

"This constitutes yet another example of a new drug that is going to improve the duration of disease control for each patient," said Paul Richardson, a physician at the Dana Farber Cancer Institute in Boston who was involved in preclinical and early clinical studies of Revlimid (lenalidomide). "Within three years, we have three major new drugs that I characterize as backbone drugs in the treatment of this disease that will help control it for longer."

Celgene's existing commercialization team will target the same 9,000 to 10,000 hematologists and oncologists that are pursued for Revlimid sales in myelodysplastic syndromes (MDS), its initial indication. That 118-person sales force also pushes Thalomid (thalidomide) for multiple myeloma, one of the other two drugs hailed by Richardson.

Barer said shipments of the new Revlimid doses would begin in a week.

The drug will be priced higher on a per-capsule basis than it is for MDS, in which lower doses are used. The 25-mg dose will cost $295 per pill, meaning that a 21-day treatment cycle will cost $6,195. The 15-mg dose will cost $5,880 over the same period.

Christopher Raymond, an analyst with Robert W. Baird & Co., said in a research note that he is modeling "a robust uptake" through this year. Its initial sales, booked in the first quarter following the MDS approval, totaled $32 million. About 70 percent of that amount came from MDS prescriptions, said Brian Gill, Celgene's senior director of corporate communications. The remainder represented off-label use, mostly for multiple myeloma.

Raymond said consensus estimates peg second-quarter sales at $51 million, and his full-year projections total $260 million. Many in the analyst community expect Revlimid to reach blockbuster status in the next four to five years.

Some have forecasted that its growth would cannibalize sales of Thalomid, which has a less tolerable profile, but Gill told BioWorld Today that such thinking is shifting as both products could be part of a multidrug regimen that extends patients' lives well beyond the disease's four-year survival rate. Thalomid's first-quarter sales reached $107 million, and the other fairly new product in the multiple myeloma space, Velcade (bortezomib, from Millennium Pharmaceuticals Inc.), generated $53.4 million in first-quarter sales.

Richardson praised the array of treatment options that have resulted of late: combinations of those three drugs with dexamethasone, combinations with one another, as well as single and sequential administrations.

"All three of those drugs will find their place in a cyclic treatment regimen," Gill said.

Celgene said multiple myeloma is the second most common blood cancer in the U.S., affecting nearly 50,000 people. Worldwide, about 300,000 people have the disease. About 14,600 new domestic cases are diagnosed annually, and about 12,000 Americans are expected to die from the disease this year.

The Multiple Myeloma Research Foundation, of Norwalk, Conn., applauded the approval and lauded Celgene's efforts for working to treat the disease, which has few available treatment options.

The company filed its supplemental new drug application at the beginning of the year. The submission was based largely on "meaningful clinical data" from a pair of Phase III trials that hit their primary endpoint, time to disease progression.

Specifically, Revlimid combined with standard therapy delayed the progression of multiple myeloma in relapsed or refractory patients for nearly a year. (See BioWorld Today, March 8, 2005.)

"It represents a paradigm shift, in terms of outcome," Richardson said, later adding that slowing the cancer's progression importantly is accompanied by a better quality of life than what's offered by transplants and other treatments. "It's a total change in the landscape to a disease that's chronic, with manageable side-effect profiles becoming very important in how we use these drugs."

Not surprisingly, though, Revlimid's label includes warnings related to its risk for birth defects and deep vein thrombosis, as well as neutropenia, thrombocytopenia and pulmonary embolisms.

An analogue of thalidomide, it is available only through a restricted distribution system that includes a risk-management program, though Revlimid's tolerability profile means that it can be used for a much longer period than Thalomid.

The FDA first approved Revlimid at the end of last year for patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

That clearance, for 5-mg and 10-mg capsules, was based on Phase II results presented three months earlier to an advisory committee. (See BioWorld Today, Sept. 15, 2005, and Dec. 29, 2005.)

Celgene is eyeing a wide potential for Revlimid, which has been shown "promising clinical responses" in other blood cancers, Gill said. "There's something about Revlimid with these so-called B-cell-derived blood cancers where there is a lot of clinical efficacy."

Already, the company has applied for multiple myeloma and MDS approvals in Europe, with decisions expected early next year. Celgene also plans to expand the drug into other worldwide markets in those indications, and Barer said its commitment extends to global registration studies for chronic lymphocytic leukemia and non-Hodgkin's lymphoma in the second half of this year.

On Friday, Celgene's stock (NASDAQ:CELG) gained 20 cents to close at $47.43.