The biggest reason the FDA’s recent approval of Fotivda is important for adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies, according to an expert from the Vanderbilt-Ingram Cancer Center, is that it offers them a very tolerable treatment option that may preserve quality of life.
The Food and Drug Administration’s (FDA) recent approval of Fotivda (tivozanib) is significantly important for adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies as it provides them with another tolerable treatment option, according to an expert from the Vanderbilt-Ingram Cancer Center.
“This drug has a very long regulatory history; it took a long time to get approved, and I think the biggest reason it's important is that it's very well tolerated,” Dr. Brian Rini, chief of clinical trials at the Vanderbilt-Ingram Cancer Center, said in an interview with CURE®. “And it's approved in a refractory space where there are certainly other options. But as a patient gets more and more lines of therapy, their ability to tolerate therapy goes down, and they become, unfortunately, more beat up from their disease.”
As cure rates ultimately go down in the refractory setting, Rini explained, the focus surrounding a drug shifts toward how tolerable it is.
“The single advantage of this drug is tolerability,” he said. “And especially in this setting, tolerability is extremely important.”
Traditionally, Rini noted, patients are aggressively treated in an upfront setting. And while some patients may be cured and have long-term disease control, many unfortunately go on to require additional lines of therapy.
“We can never have too many active drugs in cancer,” Rini said. “It's not like, ‘oh gee, we have enough active drugs. Let's stop.’ That never happens. Even though (Fotivda is) similar in some respects to other VEGF tyrosine kinase inhibitors, it's very unique in some respects, and I think that's the best part of the approval.”
The FDA based its decision on data from the phase 3 TIVO-3 trial, which was designed to evaluate Fotivda compared with Nexavar (sorafenib) in 350 patients who had received two or three prior lines of therapy. Treatment with Fotivda was associated a median progression-free survival of 5.6 months compared with 3.9 months for those who were treated with Sutent. The objective response rate was 18% for the Fotivda group (175 patients) and 8% for the Sutent group (175 patients). Median overall survival, however, was higher in the Sutent group (19.2 months) than in the Fotivda group (16.4 months).
Rini explained that the side effect profile associated with Fotivda is similar to what is seen with other tyrosine kinase inhibitors. The therapy can cause high blood pressure which needs monitoring and management if necessary, he said. But otherwise, side effects, including ones that are considered severe, are quite low.
“From a patient standpoint … it’s friendly from that perspective, because there shouldn't be a lot of … interruptions in a patient's life,” he said. “That becomes more and more important as you go through (treatment).”
Rini stressed that patients should stay on whatever therapy they are receiving if they are experiencing durable responses to treatment and are tolerating it.
“I never take a patient off the therapy that’s working,” he said. “No matter what new drug comes along, if you’re on a drug that’s working, then keep taking it. But patients always want more options, right? They want to know that there’s something else out there if (the therapy they’re on) fails.”
With that said, Rini reiterated that because of the tolerability associated with the use of Fotivda, he would recommend giving the treatment a chance in patients who have failed previous lines of therapy. At the very least, he said, the treatment will not significantly harm patients and there’s a good chance of helping them in some way.
“I think from a patient perspective, it's another option that's potentially in their future,” Rini concluded.
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