Semuloparin was designed to treat patients with certain cancers at higher risk for blood clots.
The oncologic drugs advisory committee said the findings of the phase 3 SAVE-ONCO clinical trial raised two concerns. First, it said it wasn’t clear that the population studied to determine the efficacy of the drug was the right target population since the efficacy outcome was only 3.4 percent among the participants on the placebo. Second, the death rates between the placebo and semuloparin groups were closely matched at 5.3 percent vs. 5.2 percent, throwing into doubt the value of the study for the patient population chosen.
MedPage Today noted that committee members repeatedly questioned whether the patient population and chemotherapy drug for the study were appropriate. It also called attention to the stilted exchange between the drugmaker and the regulators.
Several panelists expressed “confusion” at the answers provided by Sanofi-Aventis. Others, after detailed explanations by researchers, simply said, “So, you don’t have the answer.”
Businessweek also called attention to the FDA’s lack of satisfaction from the answers it got at the hearing.
“We still have a lot of unanswered questions,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Drug Products, told the panel at the meeting. “You also have to define in labeling a patient population that is most likely going to benefit from this drug. This has been really the crux of the reason why we brought it to the committee.”
Sanofi has not had a new drug approved for two years. Its Genzyme division is waiting for a decision on MS drugs abagio and lemtrada. The French pharmaceutical company with U.S. headquarters in Bridgewater, New Jersey is also awaiting a decision for a cancer drug it has developed with Regeneron Pharmaceuticals (NASDAQ:REGN) called zaltac, expected Aug. 4. Though data from late-stage trials for prostate cancer have not been promising, its application for colorectal cancer has met with more favorable outcomes.