FDA pipeline preview, October 2007

Key Points

Approvable designations

• Valrubicin (Valstar, Indevus) for the treatment of bacillus Calmette-Guerin (BCG)-refractory carcinoma in situ of the urinary bladder (chemistry, manufacturing, and controls NDA supplement)

•Pancrelipase (Creon, Solvay) for the treatment of pancreatic exocrine insufficiency as is often associated with cystic fibrosis and chronic pancreatitis

•Raltegravir (Isentress, Merck) in combination with other antiretroviral therapy for the treatment of HIV infection in treatment-experienced patients with ongoing viral replication despite existing therapy

Nonapprovable designations

•Mifamurtide (L-MTP-PE [formerly Junovan], IDM Pharma) for the treatment of nonmetastatic osteosarcoma

Fast-track designations

•Recombinant human antithrombin (Atryn, GTC Biotherapeutics) for the treatment of hereditary antithrombin deficiency

•Picoplatin (Poniard) for the second-line treatment of refractory or resistant small cell lung cancer (SCLC)

•T4N5 liposome lotion (Dimericine AGI Dermatics) for the treatment of solar and ultraviolet photosensitivity in patients with xeroderma pigmentosum

•Oral azacitidine (Pharmion) for the treatment of myelodysplastic syndromes

•ANX-510 (CoFactor, Adventrx) in combination with 5-fluorouracil (5-FU) and bevacizumab for the initial treatment of metastatic colorectal cancer

•Vincristine (Marqibo, Hana) for the treatment of adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia in second relapse or who have failed 2 lines of prior therapy

Priority review

•Sorafenib (Nexavar, Bayer/ Onyx) for the treatment of hepatocellular carcinoma

Orphan drug designations

•Bendamustine (Treanda, Cephalon) for the treatment of chronic lymphocytic leukemia

•MB07133 (Metabasis Therapeutics) for the treatment of hepatocellular carcinoma

•ALS-357 (Advanced Life Sciences) for the topical treatment of metastatic melanoma

•MGCD0103 (MethylGene/ Pharmion) for the treatment of Hodgkin's lymphoma