|FDA rejects sacituzumab govetecan for CMC issues|
Janssen has just received approval for their erdafitinib molecule (BALVERSA) for the treatment of metastatic urothelial carcinoma. Meanwhile, Immunomedics sacituzumab govetecan (IMMU-132) is targeting the same type of cancer and has been showing promise in the clinic:
However, the approval of IMMU-132 has been held up by the FDA:
So in the meantime, Immunomedics is partnering with Jannsen to promote their product with the agreement that the partnership will end upon the approval of IMMU-132 where they will become a competitor.
Is this a great opportunity for Immunomedics to salvage some of the US marketing machinery that they were building for the IMMU-132 rollout? Or is this going to undercut their marketshare by promoting a competitor?
What do you think?