News That Matters

Tag: encounters

Promising new drug for aggressive stage IV breast cancer encounters setback

Promising new drug for aggressive stage IV breast cancer encounters setback

Health
Federal approval of a highly anticipated breast cancer drug was delayed by the Food and Drug Administration this week. The drug, sacituzumab govitecan, which is produced by Immunomedics, was previously designated a "breakthrough therapy" by the FDA “based on preliminary evidence that it demonstrates substantial improvement over existing therapies for a life threatening disease.” According to Michael Pehl, president and CEO of Immunomedics, the reason the medication was not approved for wide availability was due to “issues...exclusively focused on chemistry, manufacturing and control matters” and that “no new clinical or preclinical data need[s] to be generated.” He added, “We are going to request a meeting with the FDA as soon as possible &hell...