Franchise Management Likely To Be Theme Of 2015 Oncology Approvals
This article was originally published in Pharmaceutical Approvals Monthly
Lung cancer will be a battleground in 2015, as the big pharma oncology players jockey for position in immuno-oncology while filling out their targeted therapy portfolios.
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With more than 40 novel agents under FDA review – and seven approvals already – prospects are good for 2015 to be another stellar year for new molecular entity and novel biologic approvals. Supplemental indications with “breakthrough” designations and the first biosimilars could challenge the primacy of NMEs in the approval narrative.
The oncology community believes that immunotherapy will be foundational, in the same way that combination chemotherapy became the backbone of treatment in the 1970s. The marching order is to trial broadly, quickly, making clinical development particularly well-suited for Big Pharma.
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months.