A New Drug Is Helping Cervical Cancer Patients Live Longer

After receiving accelerated approval from the Food and Drug Administration (FDA) in 2021, Tivdak (tisotumab vedotin-tftv) received traditional approval last week. The drug is for those with recurrent or metastatic cervical cancer who are on or who have received chemotherapy, a group of patients that, according to experts, has had less-than-ideal treatment options previously.

Marta Crispens, MD, a professor and director in the division of gynecologic oncology at Vanderbilt University Medical Center, said that cervical cancer research has vastly improved from when she completed her fellowship training in 1998. 

“We had really not seen significant advances in the treatment of this disease until very recently,” Crispens said. “If a patient had advanced or recurrent disease, we really just had some standard chemotherapy options that honestly weren’t very effective and had a lot of side effects.”

The drug, which belongs to a group of medications known as antibody-drug conjugates, is in line to replace older medications like topotecan and gemcitabine. Tivdak’s role is to disrupt the replication of the cell. Joshua G. Cohen, MD, medical director of gynecologic cancer at City of Hope Orange County, likens the drug’s structure to a dumbbell and its role to that of a smart bomb. 

“Picture the way a dumbbell is shaped: one end is like a receptor with a target. We have the linker—which is the straight part of the dumbbell—and on the other side, the killing agent,” Cohen said. “That agent blocks something called microtubules—the skeletons of cancer cells—from continuing to divide.”

The medication is given intravenously over a period of thirty minutes every three weeks.

FDA approval comes after a randomized clinical trial which confirmed the effectiveness of the drug. Patients who were taking Tivdak lived two months longer at the median than their counterparts who received chemotherapy.

“Recurrent or metastatic cervical cancer is a particularly devastating and mostly incurable disease, and patients are in need of survival-extending treatment options,” drug manufacturer Pfizer said in a statement. The “full approval by the FDA reinforces the important role of Tivdak for these patients, as the first antibody-drug conjugate with statistically significant prolonged overall survival data.”

Managing Side Effects

Side effects of Tivdak are similar to reactions caused by a typical chemotherapy regimen, like fatigue, constipation, and nausea. It has also led to adverse reactions like peripheral neuropathy and eye issues.

These side effects are something that medical practitioners have to keep in mind when they decide to prescribe this course of treatment, particularly eye damage, Noelle Cloven, MD, an associate professor at Texas Christian University’s Burnett School of Medicine and a gynecologic oncologist with Texas Oncology at the Fort Worth Cancer Center, told Verywell.

“Patients who are on this treatment have to use eyedrops to protect from getting dry eyes, eye irritation events, and vision disturbances,” she said. “These side effects are reversible with different things like holding the drug or reducing the dose.”

Peripheral neuropathy, a condition where your extremities can begin to tingle or go numb, can be treated via medications like gabapentin.

Getting New Treatments May Require Self-Advocacy

Cloven, whose department had patients who participated in the trial that led to the FDA approval, said that clinical trials are a key component in improving patient outcomes for those with cervical cancer.

“Always be on the lookout for clinical trials. It’s really important that patients are aware,” she said. “Often, patients don’t need to travel; [the medication] can be administered close to home.”

Cloven and Cohen both emphasized that good treatment often requires self-advocacy and research about treatment options.

“You may or may not be a candidate, but you never know until you ask,” Cohen said, “Many patients are cared for by doctors who mean well, but may not be experts in gynecologic cancer, or perhaps they’re not aware of the new release.”

Cohen said there also needs to be a focus on prevention.

“We need to do a better job in the U.S. with vaccination. HPV vaccination is the best way to prevent cervical cancer,” he said.