Trodelvy (sacituzumab govitecan) is a targeted cancer treatment approved by the FDA for three specific uses: metastatic triple-negative breast cancer, metastatic hormone receptor-positive/HER2-negative breast cancer, and metastatic urothelial (bladder) cancer. It belongs to a class of drugs called antibody-drug conjugates, which deliver chemotherapy directly to tumor cells rather than flooding the entire body. All three approvals are for cancers that have already been treated with other therapies and continued to grow.
Triple-Negative Breast Cancer
Trodelvy’s most established use is in metastatic triple-negative breast cancer (TNBC), a form that lacks the three most common receptors targeted by breast cancer drugs. This makes it harder to treat, and options narrow quickly when initial therapies stop working. Trodelvy is approved for adults whose cancer can’t be surgically removed and who have already received at least two prior treatments, with at least one given after the cancer spread.
The results from the pivotal ASCENT trial showed meaningful improvements over standard chemotherapy. Patients receiving Trodelvy lived a median of 11.8 months compared to 6.9 months with conventional chemo, nearly doubling the time before the disease worsened (4.8 months vs. 1.7 months). These numbers represent medians, meaning roughly half of patients did better and half did worse, but the overall pattern was consistent across patient subgroups.
More recently, the National Comprehensive Cancer Network (NCCN) updated its guidelines to recommend Trodelvy as a preferred first-line option for certain TNBC patients, not just those who’ve failed multiple treatments. For patients whose tumors don’t express PD-L1 and who don’t carry BRCA gene mutations, Trodelvy now holds a top-tier (category 1) recommendation upfront. It’s also recommended in combination with the immunotherapy drug pembrolizumab for PD-L1-positive TNBC as a first-line option.
HR-Positive, HER2-Negative Breast Cancer
Trodelvy is also approved for metastatic breast cancer that is hormone receptor-positive and HER2-negative. This is the most common subtype of breast cancer, but the approval applies specifically to patients who have already tried hormone-based therapy plus at least two additional treatments after the cancer spread. In other words, it’s reserved for later in the treatment journey when other options have been exhausted.
In the TROPiCS-02 trial, Trodelvy extended median overall survival by 3.2 months compared to standard chemotherapy, with higher tumor response rates as well. While 3.2 months may sound modest, in heavily pretreated metastatic breast cancer, where each successive therapy tends to offer diminishing returns, this is considered a clinically meaningful gain.
Urothelial (Bladder) Cancer
The third approved use is for locally advanced or metastatic urothelial cancer, which includes cancers of the bladder, ureter, and renal pelvis. This approval covers patients who have already received platinum-based chemotherapy and an immunotherapy drug (a PD-1 or PD-L1 inhibitor). In the TROPHY-U-01 trial, 28% of patients saw their tumors shrink meaningfully with Trodelvy.
One important distinction: this particular approval was granted under the FDA’s accelerated approval pathway, which is based on tumor response rates rather than proof of longer survival. Continued approval depends on results from confirmatory trials still underway.
How Trodelvy Works
Trodelvy is an antibody-drug conjugate, which is essentially a guided missile for cancer cells. It has two components: an antibody that locks onto a protein called Trop-2, which is found at high levels on the surface of many solid tumors, and a potent chemotherapy payload (a drug called SN-38, related to the chemo agent irinotecan). Each antibody molecule carries roughly eight copies of the chemo drug.
Once the antibody attaches to Trop-2 on a cancer cell, the entire package gets pulled inside the cell. In the acidic environment inside the cell, the chemical link connecting the chemo drug to the antibody breaks apart, releasing SN-38. This drug then damages the cancer cell’s DNA and blocks its ability to replicate, ultimately killing it. The released chemo can also leak out and kill neighboring tumor cells that may not have as much Trop-2 on their surface, a phenomenon called the bystander effect. This dual action, targeted delivery plus local spillover, is part of what makes the drug effective even in tumors where Trop-2 expression varies from cell to cell.
How Treatment Is Given
Trodelvy is administered as an intravenous infusion at a dose based on body weight (10 mg/kg). You receive it on days 1 and 8 of a 21-day cycle, meaning two infusion days followed by about two weeks off before the next cycle begins. Treatment continues as long as the cancer is responding and side effects remain manageable.
Before each infusion, you’ll receive medications to prevent nausea and allergic reactions. Blood work is done regularly throughout treatment to monitor your white blood cell counts and catch potential complications early.
Side Effects to Expect
Trodelvy carries a boxed warning, the FDA’s most serious safety alert, for two side effects: dangerously low white blood cell counts (neutropenia) and severe diarrhea.
Neutropenia occurred in 64% of patients in clinical trials, with about half (49%) experiencing severe drops. This matters because white blood cells fight infection, so significant drops can leave you vulnerable to serious illness. About 6% of patients developed febrile neutropenia, meaning a dangerously low count paired with fever, which requires immediate medical treatment. Your care team will monitor your blood counts on a regular schedule and may prescribe white blood cell-boosting injections if counts fall too low.
Diarrhea was equally common, affecting 64% of patients, though severe cases were less frequent at 11%. When diarrhea occurs, it needs to be treated promptly with anti-diarrheal medication and fluid replacement. If it becomes severe, treatment may be paused until it resolves.
Other common side effects include fatigue, nausea, hair loss, and decreased appetite. These are consistent with what you’d expect from a chemotherapy-based treatment, though the targeted delivery system is designed to concentrate the drug’s activity at tumor sites rather than throughout the body.