RB, LGND's press release is light on the "spontaneous" response rate which may be impacted by other drugs (I believe that these advanced patients were on at least one PI). However, both studies gave a similar response rate and the end point seemed to be fair rigorous (shrinking of tumor). I looked up the BMY press release on Taxol, and it was even vaguer than LGND's. They indicated that over 50% of the KS patients benefited, but it looks like one of the end points was pain relief and response rate was relatively short:
Oncology Drugs Advisory Committee Recommends TAXOL(R) for
Kaposi's Sarcoma
PRINCETON, N.J., June 23 /PRNewswire/ -- The Oncology Drugs Advisory
Committee (ODAC) today recommended that the U.S. Food and Drug Administration
approve TAXOL for the treatment of Kaposi's Sarcoma (KS).
"As a research-based company, and a leader in the fight against AIDS,
Bristol-Myers Squibb is extremely pleased by ODAC's recommendation that the
FDA approve TAXOL for the treatment of Kaposi's sarcoma," said Rick
Winningham, President, Bristol-Myers Squibb Oncology/ Immunology Division.
"With the Committee's favorable reception of the data, we hope for a rapid FDA
approval."
Kaposi's sarcoma is a rare form of cancer, but it is the most frequent
malignancy in HIV-infected individuals. Current estimates indicates that of
the 202,535 people living with AIDS through June 1996, about 20% (or 40,000
patients) are or will be affected by Kaposi's sarcoma, according to estimates
provided by the Centers for Disease Control and Prevention.
In clinical studies, a high proportion of patients treated with TAXOL
benefited from prolonged control of the disease. The median duration of
response was 8.2 months. For all patients, the median time to progression of
disease was 6.5 months. In addition, TAXOL therapy provided improved symptom
reduction, including reduced edema (fluid accumulation), healing of lesions on
feet, healing of facial lesions, reduction of pain, reduction of pulmonary
lesions and general improvement of the patient's performance status. The most
common side effects among patients in the studies was myelosuppression (a
reduction in bone marrow cells). Other side effects included alopecia,
arthralgia/myalgia and peripheral neuropathy.
"This is another major step for the company in its ongoing commitment to
explore new uses for TAXOL," said Mr. Winningham. "Further, we believe this
application demonstrates our commitment to fighting HIV/AIDS. Our immunology
portfolio currently includes Videx(R), ZERIT(R) and Megace(R) OS, and we are
optimistic about adding TAXOL to this distinguished line of medicines."
Bristol-Myers Squibb (NYSE: BMY) is a diversified worldwide health and
personal care company whose principal businesses are pharmaceuticals, consumer
products, nutritionals and medical devices. It is a leading maker of
innovative therapies for cardiovascular, metabolic and infectious diseases,
central nervous system and dermatological disorders, and cancer. The company
is a leader in consumer medicines, orthopaedic devices, ostomy care, wound
management, nutritional supplements, infant formulas, and hair and skin care
products. The company will invest about $1.5 billion in research and
development in 1997.
SOURCE Bristol-Myers Squibb Company
CONTACT: Jane A. Kramer, 609-252-5185, or pager, 800-475-8947, or
John Kouten, 609) 252-5456, or pager, 800-461-7518 /Bristol-Myers
Squibb press releases available through Company News On-Call by
fax, 800-758-5804, ext. BMYFAX (269329) or at
prnewswire.com |
