Subject: Chiron's Drug for Kidney Cancer Heads For Approval
Date: Published: 1/20/92 (106 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Health:
    Chiron's Drug for Kidney Cancer Heads
    For Approval, but Sales May Be Limited
    ----
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    Chiron Corp. 's new drug for advanced kidney cancer appears
 headed for Food and Drug Administration approval within
 months, but its high cost and severe toxicity may limit early
 sales to a narrow market.
    Rebuffed 18 months ago, interleukin-2 on Friday won the
 recommendation of an FDA advisory panel after a five-hour
 hearing.  Studies indicate IL-2 offers a chance of complete
 remission for a few patients, yet it may hasten death for
 others -- a risk which confines its use to patients able to
 bear its harsh and potentially lethal side effects.
    Already approved in Europe at prices up to $9,000 per
 treatment, IL-2's final market clearance must come from the
 office of FDA Commissioner David Kessler.  The commissioner
 isn't bound by panel recommendations, but they are typically
 given great weight.
    Chiron shares, already buoyed by a market evidently
 expecting success, rose to $72 before settling down to close
 at $69, up 25 cents a share.  Chiron acquired the IL-2 product
 last month when it bought the drug's developer, Cetus Corp.,
 for stock valued at $650 million.  Both biotechnology
 companies are based in Emeryville, Calif.
    "We're obviously pleased," said Chiron President Edward
 Penhoet.  "We expected this result, but you can never be
 sure."  Chiron's marketing plans for IL-2 include intensive
 training on how to mute the drug's side effects, and boost a
 patient's chances of benefit.
    Current European sales of IL-2 run $15 million a year, and
 he forecast that its initial U. S. market could double that.
 IL-2 is a genetically engineered copy of a natural human
 protein which boosts the numbers and the tumor-fighting power
 of white blood cells.
    IL-2, not yet priced in the U. S., sells in Europe for
 $7,000 to $9,000 per course of treatment.  Because patients
 must take IL-2 under the close monitoring of an intensive
 care unit, the cost of hospitalization will boost total cost
 to $30,000 to $45,000 per treatment.  Patients who respond
 well to IL-2 often take a second or even a third course of
 the drug -- doubling or tripling the ultimate bill.
    For some 20,000 patients newly diagnosed with kidney
 cancer each year in the U. S., IL-2 represents a weapon that
 is distinctly double-edged:  high risk but also potentially
 high reward.  About 60% of kidney cancer metastasizes or
 spreads beyond its original site, leaving patients with no
 cure and a dismal prognosis of six to 12 months.  Studies
 presented at Friday's hearing indicate those odds are
 starting to improve.
    Of 255 patients studied, Chiron researchers said at the
 hearing that IL-2 made tumors shrink or disappear in 37
 patients, or 15%.  That included nine patients, or 4%, who
 went into complete remission.  The good responses have lasted
 nearly two years on average, and eight of the nine patients
 in complete remission remain cancer-free.  But 11 patients
 died from side effects of treatment, mostly lethal heart and
 lung problems provoked by the stress of massive fluid
 retention in the body.
    "Approval of IL-2 represents an important step in the
 development of immunotherapy," said Eugene Schonfeld,
 president of the National Kidney Cancer Association.  Mr. 
 Schonfeld had lectured the FDA panel on its "moral
 obligation" to approve IL-2.  He held the panel partly
 accountable for some 15,750 kidney cancer deaths that
 occurred since it declined to sanction sale of the drug back
 in June 1990.
    But the cool scholarly presentation by Chiron was much
 more persuasive than Cetus's heated and impetuous bid for
 approval 18 months ago.  FDA panel chairman Jerome Groopman of
 Harvard University this time called the clinical responses
 "impressive and {not} anecdotal."  Even though the drug has
 yet to lengthen lifespans for most patients, it offers vivid
 hope for a few.  Pioneering IL-2 researcher Steven Rosenberg
 of the National Cancer Institute documented some graphic
 recoveries with slides of bulky tumors melting away to a
 shadow or less.
    It wasn't enough for the lone dissenter in Friday's 7-1
 vote.  "I remain unconvinced," said Ernest Borden of the
 Medical College of Wisconsin.  He noted the drug's difficult
 risk-benefit ratio:  "twice as many patients suffered severe
 neurological toxicity ...as those who responded
 favorably."
    "IL-2 isn't a cure," said National Cancer Institute
 Director Samuel Broder in an interview.  Still, he noted,
 winning rare and difficult remissions among patients once
 deemed incurable, is an important step.  The FDA panel's vote
 validates a decade of federally sponsored research, he added.
    Dr. Penhoet confirmed Chiron's intent to build on IL-2's
 initial niche, expanding it into new uses for other cancers
 and infectious diseases, such as acquired immune deficiency
 syndrome.  IL-2 is currently being tested in melanoma and
 AIDS, and in combination with a variety of tumor-fighting
 cells, though the executive didn't forecast how soon Chiron
 might seek the FDA's nod.

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