FDA Panel OKs Idec’s Zevalin for Cancer
A Food and Drug Administration advisory panel Tuesday endorsed Idec Pharmaceuticals’ Zevalin, putting it on track to become the first ever radioactive drug.
The 15-member panel, meeting in Bethesda, Md., voted to recommend the lymphoma treatment. The action came fore federal agencies shut down in the wake of the terrorist attacks on the Pentagon and the World Trade Center.
The committee endorsed Zevalin for patients with non-Hodgkin’s lymphoma that defies other treatment. In a clinical trial, the experimental drug helped 73% of gravely ill patients who used it, though many of them relapsed after 11 months.
Idec, in a lengthy filing submitted to the FDA, said Zevalin does not improve overall survival. But the San Diego-based company argued the drug benefits patients because it reduces the size and number of tumors for a sustained period of time. The company said that in one clinical trial, 30% of patients had no sign of tumors one month after taking Zevalin.
Dr. Edward Sausville, a cancer researcher at the National Institutes of Health, called Zevalin “groundbreaking.” The FDA committee member said Idec’s research was “very provocative and impressive,” according to Bloomberg News.
More than 50,000 Americans annually develop non-Hodgkin’s lymphoma, a cancer that attacks the immune system. It is the fifth-leading cause of cancer death.
The panel recommendation was significant for Idec, a 15-year-old biotechnology company with one other product. Idec has been in a race with Seattle biotechnology company Corixa to be the first with a radioactive lymphoma treatment.
Analysts said the FDA panel vote puts Idec at least three months ahead of Corixa, whose drug, Bexxar, hasn’t yet been scheduled for a government review. The earliest that such a review could take place is December, analysts said.
The first radioactive lymphoma drug to receive FDA approval is expected to capture the market for the late-stage treatment, which is limited in size but potentially lucrative.
First-year sales of Zevalin could range between $50 million and $70 million, with costs per treatment ranging between $15,000 and $20,000, analysts said. Idec hasn’t announced a price.
Separately, Idec said it filed a federal patent lawsuit against Corixa and its marketing partner, GlaxoSmithKline, over the radioactive drugs.
Idec is seeking a declaratory judgment that Zevalin does not infringe patents held by its competitors, who couldn’t be reached for comment. The move is an effort by Idec to prevent legal disputes from eroding its timing advantage.
Zevalin is a bioengineered antibody that carries a payload of a radioactive chemical, yttrium 90. The antibody binds to the surface of tumor cells, bathing them in cancer-fighting radioactivity. Lymphoma cancers are highly susceptible to radiation.
The panel noted that Zevalin is toxic and recommended it only for patients with no other treatment options. More than half of the patients who took Zevalin in clinical trials suffered depletion of infection-fighting white blood cells and platelets, which arrest bleeding, though their blood counts returned to normal within four weeks.
A commonly used chemotherapy drug, chlorambucil, causes those side-effects in less than 20% of patients.
Patients nonetheless tolerate the radioactive drugs well, said Dr. Morton Coleman, director of the center for lymphoma and myeloma at the Weill Medical College of Cornell University-New York Presbyterian Hospital.
Lower blood counts are less bothersome to patients than vomiting and hair loss associated with chemotherapy, he said.
“They aren’t hard to take,” he said.
Idec, in documents presented to the FDA, argued Zevalin is superior to Bexxar, which uses a different radioactive chemical, iodine 131. It said patients who use Bexxar can expose family or others in close proximity to radiation. But analysts and physicians interviewed discounted that risk. Corixa didn’t respond to a request for comment.
Zevalin would be the first drug that Idec manufactures and markets on its own. Its other drug, Rituxan, is jointly marketed with biotechnology giant Genentech of South San Francisco.
Rituxan is an engineered antibody that is used to treat lymphoma. It has been found to be effective in 48% of patients. While chemotherapy remains the first-treatment option for lymphoma, Rituxan is becoming increasingly popular among physicians because, besides being effective, its only side-effects are transient flu-like symptoms.
Analysts expect sales of Rituxan to reach $750 million this year, as the treatment approaches blockbuster status. Idec and Genentech share profit from the drug.
For the six months ended June 30, Idec had income of $45.9 million on revenue of $106.6 million. Revenue doubled and income more than doubled from the same period in 2000.
Idec shares fell $1.46, or 2.5%, to $56.15 in Monday’s trading of 8.4 million shares, more than double the stock’s three-month daily average. U.S. markets were closed Tuesday after the terrorist attack at the World Trade Center in New York.
