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BREAKING NEWS: FDA approves elotuzumab

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BREAKING NEWS: FDA approves elotuzumab

Bring it on! The FDA has approved elotuzumab (Empliciti) for use in relapsed multiple myeloma patients; the third new drug approval in three weeks!

Elotuzumab was the first immunotherapy developed to fight myeloma. But unlike daratumumab, elo only works when combined with one of the established novel therapy agents in the IMiD class of drugs (Thalomid, Revlimid, Pomalyst).

I’ve seen the data. Elo isn’t overly impressive. But I’m excited that the FDA would approve it. That means they get it: that a drug doesn’t need to be a blockbuster in order to help some of us live longer.

Here’s MMRF President, Walter Capone, take on the today’s approval:

Statement from Walter M. Capone, President and CEO of the Multiple Myeloma Research Foundation (MMRF) Regarding the Decision by the U.S. Food and Drug Administration (FDA) to Approve Empliciti® (elotuzumab), for the treatment of people with multiple myeloma who have received one to three prior medications

“The approval of elotuzumab marks another important milestone in the treatment of multiple myeloma in a short period of time. Since 2008, the Multiple Myeloma Research Consortium (MMRC), MMRF’s clinical network, has been a key partner in the development of elotuzumab, assisting in the initiation of four clinical trials, including one that led to the pivotal Phase III ELOQUENT-2 study which supported this approval of elotuzumab. Two of these trials are ongoing and investigating the use of the elotuzumab in newly diagnosed multiple myeloma and smoldering multiple myeloma.

As a part of our ongoing commitment to the development of elotuzumab in partnership with the Bristol-Myers Squibb’s (BMS) team, the MMRF and MMRC worked to progress early stage clinical trials by facilitating expert review of trial protocols, expediting study contracting and initiation, providing training to the clinical trial sites, speeding study completion by activating patient enrollment and communicating trial results. Additionally, by supporting BMS’ expanded access program (EAP), the MMRF has also played a key role ensuring that patients had access to elotuzumab while it was being reviewed by the FDA.”

– Walter M. Capone, President and CEO of the Multiple Myeloma Research Foundation

Bristol Myers logoElotuzumab is being developed and marketed by Bristol-Myers Squibb. I’ll do a follow up post with more specifics about how and when elo works best.

There are two more immunotherapies that could also be approved in the next year or two: SAR650984 and MOR202. Both target the same CD38 receptor.

Three FDA approvals in less than a month. How awesome is that?

Feel good and keep smiling! Pat