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Celgene, Roche/Immunogen and Dynavax are all likely to see FDA approvals
Norwood, MA (PRWEB) January 29, 2013
Major market-moving events noted in BioPharm Insight’s February Catalyst Monitor include potential US therapeutic approvals for Celgene, Roche/ImmunoGen and Dynavax Technologies.
After notification from the US Food and Drug Administration (FDA) that the Oncologic Drugs Advisory Committee meeting scheduled for 8 November 2012 was canceled, experts agreed Celgene’s pomalidomide is still on track to be given the go-ahead. The fact that the FDA canceled the meeting as opposed to postponing it as they frequently do suggests a decision has been made. Experts interviewed noted the only concern with pomalidomide could be the risk of second primary malignancy but that the drug has a similar side-effect profile to Celgene’s approved multiple myeloma drug, Revlimid (lenalidomide), and should thus be green-lighted without any problem.
In November, Roche/ImmunoGen announced the FDA had accepted their Biologics License Application and granted Priority Review for T-DM1 as a treatment for unresectable locally advanced or metastatic HER2+ breast cancer patients who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy. Oncologists interviewed by this news service expected to see limited off-label use in the first-line setting after second-line approval since insurance carriers are likely to push back.
Lastly, with a Prescription Drug User Fee Act date of 24 February 2013, Dynavax’s Heplisav may see FDA approval in hepatitis B subgroups but fall short in the broader population of patients 18-70 years old. Experts are in disagreement on whether safety issues in the larger patient group warrant pre- or postmarketing studies.
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