FDA Grants Breakthrough Therapy Designation to AbbVie’s and BMS’s Elotuzumab

AbbVie and Bristol-Myers Squibb has received breakthrough therapy designation for elotuzumab for use in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in patients who have received one or more prior therapies. Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Elotuzumab is a humanized IgG1 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7, also called CS1), a glycoprotein expressed on myeloma and Natural Killer cells but not detectable in normal tissue. The company is investigating whether through both direct activation and engagement of Natural Killer cells, elotuzumab may selectively target and kill SLAMF7 expressing myeloma cells. Elotuzumab is being co-developed with AbbVie, with Bristol-Myers Squibb leading the commercialization of the agent.

To date, there have been four drugs approved with breakthrough therapy status: In 2014, Zykadia (ceritinib) was approved, and in 2013, the three drugs were approved as breakthrough therapies: Gilead Sciences’ Sovaldi (sofosbuvir) to treat chronic hepatitis C virus infection, Janssen Biotech/Pharmacyclics’ Imbruvia (ibrutinib) to treat mantle cell lymphoma, and Genentech/Roche's Gazyva (obinutuzumab) to treat chronic lymphocyte leukemia.

See related story, “AstraZeneca Leading the Way in Drug Approvals in 2014

Source: Bristol-Myers Squibb

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