FDA pipeline preview, October 2007
The latest FDA action (through October 2007) related to valrubicin (Valstar), pancrelipase (Creon), raltegravir (Isentress), mifamurtide (L-MTP-PE, formerly Junovan), recombinant human antithrombin (Atryn), picoplatin, T4N5 liposome lotion (Dimericine), oral azacitidine, ANX-510 (CoFactor), vincristine (Marqibo), sorafenib (Nexavar), bendamustine (Treanda), MB07133, ALS-357, and MGCD0103
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
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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