Celgene Corporation (CELG) received encouraging news recently with the US Food and Drug Administration (:FDA) clearing the company’s growth engine Revlimid for an additional indication. The US regulatory body approved Revlimid for treating patients suffering from mantle cell lymphoma (:MCL). The disease of the patients had either relapsed or worsened after two prior therapies, including Takeda Pharmaceutical Company’s (TKPYY) Velcade.
The US approval came on the basis of encouraging data from a multi-center, single arm, open label phase II study (MCL-001: n=134) which evaluated Revlimid in the MCL indication. We remind investors that Celgene had filed a supplemental New Drug Application (sNDA), seeking FDA approval to expand Revlimid’s label, late last year. The FDA reviewed the application on a priority basis. The US regulatory body gave its nod of approval on its assigned target date of Jun 5, 2013.
We note that Revlimid is already approved in combination with dexamethasone for treating multiple myeloma (MM) patients who have received at least one prior therapy. Revlimid is also available for treating transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality (with or without additional cytogenetic irregularities). The label expansion into the MCL indication would further boost the sales potential of the drug.
We note that the positive news from the FDA came close on the heels of the European Medicines Agency’s (:EMEA) Committee for Medicinal Products for Human Use (CHMP) recommending the EU approval of another drug at Celgene, Pomalyst.
Celgene is seeking approval for the use of Pomalyst in combination with low-dose dexamethasone for the treatment of relapsed and refractory MM patients, who have received at least two prior therapies (including Revlimid and Velcade). The disease worsened for the patients while on their previous therapy. We note that Pomalyst is already available in the US for the MM indication.
Celgene, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). Alexion Pharmaceuticals, Inc. (ALXN) and Cubist Pharmaceuticals, Inc. (CBST) look equally attractive in the biopharma space with a Zacks Rank #2 each.
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