Company

Product

Description

Indication

Action

Amgen Inc.

Stemgen

Ancestim; r-metHuSCF; recombinant human stem cell factor

Combination therapy with granulocyte-colony stimulating factor to increase progenitor blood cells (stem cells) for autologous stem cell transplants in cancer patients undergoing high-dose chemotherapy

FDA¿s Biological Response Modifiers Advisory Committee recommended approval in narrow indication (10-1 vote) but not for broader use to reduce the number of procedures for collecting blood cells (apheresis) (7/30)

Bristol-Myers Squibb Co. (NYSE:BMY)

Taxol (FDA-approved)

Paclitaxel; semi-synthetic taxane; inhibits cancer cell division by blocking microtubule assembly/disassembly; derived from needles and twigs of yew tree

Combination therapy with cisplatin as first-line treatment of advanced ovarian cancer

FDA¿s Oncologic Drugs Advisory Committee recommended approval (3/20)

Bristol-Myers Squibb Co. (NYSE:BMY)

Taxol (FDA-approved)

Paclitaxel; semi-synthetic taxane; inhibits cancer cell division by blocking microtubule assembly/disassembly; derived from needles and twigs of yew tree

Combination therapy with cisplatin for treating non small-cell lung cancer in patients who are not candidates for radiation therapy

FDA¿s Oncologic Drugs Advisory Committee recommended approval (3/20)

Cypress Bioscience Inc.

Prosorba Column (FDA-approved)

Disposable filter that uses Protein A to remove circulating immune complexes from patient¿s blood

Moderate-to-severe rheumatoid arthritis in patients who have failed 2nd-line therapy

FDA¿s Gastroenterology and Urology Device Panel recommended approval (10 to 1); with post-marketing study required (10/29)

Ligand Pharmaceuticals Inc.

Panretin Gel

Alitretinoin 0.1% (topical); 9-cis retinoic acid (derived from vitamin A)

Treatment of dermal lesions in AIDS-related Kaposi¿s sarcoma

FDA¿s Oncologic Drugs Advisory Committee recommended approval (8 to 1) (11/16)


No Comments