Celgene's Revlimid Makes Stronger Case for European Front-Line Approval

The upcoming American Society of Hematology (ASH) annual meeting is important for Celgene  (CELG) and its multiple myeloma drug Revlimid. Investors got a first look last week at a research abstract for the so-called MM-020 study of Revlimid in newly diagnosed multiple myeloma and results were as good as Celgene bulls could have hoped for.

Expanded European approval of Revlimid in front-line multiple myeloma is an important growth driver for Celgene. The company has already failed once to garner the support necessary to expand Revlimid's label, which makes data from the MM-020 study especially important. 

In June 2012, European regulators identified two main issues which prevented Revlimid expansion into front-line use. While Revlimid demonstrated a clear benefit on progression-free survival (PFS), there was no survival benefit. This wasn't really Celgene's fault because the Revlimid studies were early and the majority of multiple myeloma patients were still alive when the data were submitted to European regulators. 

The more significant knock against Revlimid was data from the studies showing an imbalance in the diagnosis of secondary primary malignancies (SPM.) Patients treated with Revlimid were more likely to develop future cancers compared to the patients in the control group. 

One could argue that the PFS benefit of Revlimid was so great that these imbalances would not matter in the long run.  That argument, however, would require a convincing and statistically significant survival benefit.  Given the early nature of the Revlimid data, Celgene could not make this case and thus had to withdraw the European application.

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