FDA Panel to Review Celgene Drug

Celgene Corporation (CELG - Analyst Report) recently announced that Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration (FDA) will hold a meeting on November 8, 2012 to review the company’s new drug application (NDA) for its oncology candidate, pomalidomide.

Celgene is seeking approval of the candidate in combination with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma (MM) patients, who have received at least two prior therapies.

We remind investors that the FDA had granted standard review (10 month review period) to the NDA for pomalidomide for the MM indication. The NDA includes data from a phase II study (MM-002) on the candidate. Celgene is also conducting an international phase III study (MM-003), evaluating pomalidomide in relapsed and refractory MM patients. Data from the study is expected by year end.

A final decision from the FDA is expected by February 10, 2013 (action date). The decision on pomalidomide is an eagerly-awaited event. Celgene is also seeking European approval for pomalidomide for the same indication.

The MM market has been in the spotlight this year. In July 2012, the FDA cleared Onyx Pharmaceuticals, Inc.’s (ONXX - Analyst Report) Kyprolis. Kyprolis was approved for use in treatment-experienced MM patients (who have received at least two prior therapies, including Takeda (TKPHF) /Johnson & Johnson’s (JNJ - Analyst Report) Velcade and an immunomodulatory agent). Moreover, the disease had progressed on or within 60 days of completion of the last therapy in those patients.

We note another key action date is coming up at Celgene next month (October 12) when the FDA is expected to decide on the company’s efforts to expand the label of its oncology drug, Abraxane, into the non-small cell lung cancer (NSCLC) indication. Celgene is looking to get Abraxane approved as a first-line therapy in advanced NSCLC patients. Abraxane is already available as a second-line therapy for metastatic breast cancer.

Our Recommendation

We currently have a Neutral recommendation on Celgene. The stock carries a Zacks #3 Rank (Hold rating) in the short run.