Ann: Patrys Acquires Novel Assets from Yale University, page-47

Just wondering if this has any bearing on our PAT SM6 development -http://seekingalpha.com/news/3195670-j-and-js-darzalex-breakthrough-therapy-earlier-line-treatment-multiple-myeloma

J&J's Darzalex a Breakthrough Therapy for earlier line of treatment for multiple myeloma
Jul 25 2016, 23:04 ET | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip
- The FDA designates Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab) a Breakthrough Therapy, in combination with Celgene's (NASDAQ:CELG) REVLIMID (lenalidomide) and dexamethasone, for the treatment of multiple myeloma (MM) patients who have received at least one prior line of therapy.
- DARZALEX is currently approved in the U.S. for the treatment of MM patients who have received at least three prior lines of therapy. Several months ago, the European Commission approved it as monotherapy in adults with relapsed/refractory MM whose prior therapy included a proteasome inhibitor [e.g. Takeda's Ninlaro (ixazomib)] and an immunomodulatory agent and have shown disease progression on the last therapy.
-Daratumumab is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of many immune cells. Once bound, it induces rapid tumor cell death through multiple mechanisms.
- Breakthrough Therapy status provides for more intensive guidance from the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA) (or supplemental NDA in this case).
Now read: Johnson And Johnson: No Time To Wait »
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