FDA ACTIONS
Centocor’s supplemental biologics license application (sBLA) for infliximab (Remicade) for treatment of ulcerative colitis has been granted priority review by the U.S. Food and Drug Administration. The sBLA is based on two phase 3 trials in patients who were unresponsive to at least one standard therapy. There are no FDA-approved therapies for moderate to severe ulcerative colitis.
The FDA has accepted Celgene’s new drug application for lenalido-mide (Revlimid) as a treatment for transfusion-dependent myelodys-plastic syndromes (MDS) patients with deletion 5q chromosomal abnormality.... Toronto-based Lorus Therapeutics’ will be allowed a rolling submission of its NDA for virulizin-2gamma (Virulizin), an experimental treatment for pancreatic cancer. The drug has received FDA fast-track and orphan drug statuses.
CLINICAL TRIALS/DRUG DEVELOPMENT
Cetuximab (Erbitux), in combination with radiation therapy, prevented the spread of head and neck cancer more effectively than radiation therapy alone, according to maker ImClone Systems. A phase 3 trial included 424 patients with advanced squamous cell carcinoma of the oropharynx, larynx, and hypopharynx.
Genentech, Biogen Idec, and Roche announced positive results from a phase 2b trial of rituximab (Rituxan) in rheumatoid arthritis patients who responded inadequately to methotrexate and had failed disease-modifying anti-rheumatic drugs. For Genentech, the study was but foam in a wave of good news. In a phase 3 study, ranibizumab (Lucentis) met its primary efficacy endpoint of maintaining vision in patients with wet age-related macular degeneration. Earlier, the company halted two National Cancer Institute-sponsored trials of trastuzumab (Herceptin) early after an analysis showed major improvements in survival rates in breast cancer patients. And, in a phase 3 study of patients with metastatic breast cancer, bevacizumab (Avastin) plus paclitaxel met its primary endpoint of improving progression-free survival, compared to chemotherapy alone.
A study in the British Journal of Haematology on a phase 2 trial of bortezomib (Velcade) showed strong single-agent and high combination (with standard therapy dexamethasone) response rates in patients with multiple myeloma.
MISCELLANEOUS
San Diego-based Avanir is expected to seek approval this year for AVP-923 (Neurodex), for uncontrollable laughter and crying in patients with MS and ALS.
RECENT FDA APPROVALS OF BIOLOGIC DRUGS
| Action date | Drug | Sponsor | Indication | Dosage form | Dosage |
|---|---|---|---|---|---|
| New drug approvals | |||||
| April 28, 2005 | Exenatide (Byetta) | Amylin, Eli Lilly | Type 2 diabetes | Subcutaneous injection | 5–10 mcg, 2× daily |
| May 31, 2005 | Galsulfase (Naglazyme) | BioMarin | Mucopolysaccharidosis VI (MPS VI) | Intravenous infusion | 1 mg/kg, 1×weekly |
| New and expanded indications | |||||
| May 18, 2005 | Infliximab (Remicade) | Centocor | New indication for psoriatic arthritis | Intravenous infusion | 5 mg/kg at 0, 2, 6 weeks, then every 8 weeks |
| May 27, 2005 | Etanercept (Enbrel) | Amgen, Wyeth | Expanded indication to improve physical function in patients with psoriatic arthritis | Subcutaneous injection | 50 mg, 1×weekly |
SOURCES: U.S. FOOD AND DRUG ADMINISTRATION, MANUFACTURERS’ PACKAGE INSERTS