Merck announced that the FDA has granted Isentress (raltegravir) tablets accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
The FDA has approved Ortho-McNeil's Doribax (doripenem for injection) as a new treatment for complicated intra-abdominal and complicated urinary tract infections, including pyelonephritis. Doribax has demonstrated activity against a wide range of Gram-positive(1) and Gram-negative(2) bacteria -- including pseudomonas -- that cause these serious infections.
GlaxoSmithKline announced the FDA has approved oral Hycamtin (topotecan) capsules for the treatment of relapsed small cell lung cancer (SCLC). Specifically, Hycamtin capsules are indicated for patients who had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment. Hycamtin capsules are the only oral single-agent chemotherapy approved for the treatment of SCLC after failure of first-line therapy. The product will be available in 2008.
Millennium Pharmaceuticals announced that the FDA granted approval for Velcade for use, without dose adjustments, in patients with impaired kidney function, including those requiring dialysis. Impaired kidney function is a common complication related to multiple myeloma, affecting approximately 30% of patients at diagnosis and a much larger percentage throughout the course of the disease.