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FDA clears Trodelvy as a first-line treatment for triple-negative breast cancer

FDA clears Trodelvy as a first-line treatment for triple-negative breast cancer

New Capabilities

A drug once reserved for late-stage patients moves to the front of the treatment line, alone or paired with Keytruda

June 24th, 2026: FDA approves Trodelvy as first-line treatment

Overview

Triple-negative breast cancer is aggressive and short on options. On June 24, 2026, the U.S. Food and Drug Administration cleared Gilead Sciences' Trodelvy as a first-line treatment, moving a drug once used only after other therapies failed to the front of the line. Six days earlier, the European Commission had done the same for patients in the EU who are ineligible for immunotherapy.

Triple-negative tumors lack the three receptors that most breast-cancer drugs target, so hormone therapies and HER2 drugs don't work. The FDA cleared Trodelvy alone for patients who can't take immunotherapy, and alongside Merck's Keytruda for PD-L1-positive tumors. The National Comprehensive Cancer Network had already added both regimens as preferred first-line options in early 2026, before the FDA formally acted.

Why it matters

Patients with the hardest-to-treat breast cancer now have a targeted drug as their first option, not their last.

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Key Indicators

38%
Lower risk of progression (alone)
ASCENT-03 cut the risk of cancer worsening or death by 38% versus chemotherapy.
35%
Lower risk of progression (with Keytruda)
ASCENT-04 cut that risk by 35% versus Keytruda plus chemotherapy.
16.5 mo
Median response duration (combo)
Trodelvy plus Keytruda held responses for 16.5 months versus 9.2 for the older regimen.
~15%
Share of breast cancers
Triple-negative disease is about one in seven breast cancers and skews younger.

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People Involved

Sara Tolaney
Sara Tolaney
Chief of breast oncology, Dana-Farber Cancer Institute

Organizations Involved

Gilead Sciences
Gilead Sciences
Pharmaceutical company
Maker of Trodelvy; holds the new first-line approval

A California drugmaker that gained Trodelvy through its 2020 purchase of Immunomedics.
U.S. Food and Drug Administration
U.S. Food and Drug Administration
Federal regulator
Granted both first-line approvals

The U.S. agency that decides which drugs can be sold and for which patients.

Timeline

April 2020 June 2026

6 events Latest: June 24th, 2026 · 1 month ago
Tap a bar to jump to that date

  1. FDA approves Trodelvy as first-line treatment

    Latest Regulatory

    The agency cleared Trodelvy alone for immunotherapy-ineligible patients and with Keytruda for PD-L1-positive tumors.

  2. European Commission approves Trodelvy for first-line TNBC

    Regulatory

    The EC granted marketing authorization for Trodelvy as monotherapy for patients with unresectable or metastatic TNBC not eligible for PD-(L)1 inhibitor therapy. It is the first antibody-drug conjugate cleared for first-line TNBC across the EU's 27 member states, plus Norway, Iceland, and Liechtenstein.

  3. NCCN adds Trodelvy to preferred first-line options

    Clinical Guideline

    The National Comprehensive Cancer Network updated its breast cancer guidelines (Version 1.2026) to list Trodelvy as a Category 1 preferred option for PD-L1-negative first-line metastatic TNBC. The Trodelvy-plus-Keytruda combination was added as Category 2A preferred for PD-L1-positive disease.

  4. First-line trial data reported

    Clinical Data

    ASCENT-03 and ASCENT-04 results showed the drug slowed cancer better than chemotherapy as an opening treatment.

  5. Full approval after ASCENT trial

    Regulatory

    The Phase 3 ASCENT trial showed longer survival, and the FDA converted the drug to regular approval for later-line use.

  6. Trodelvy wins accelerated approval

    Regulatory

    The FDA cleared Trodelvy for triple-negative patients who had already tried at least two prior therapies.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

September 1998

Herceptin approval (1998)

The FDA approved trastuzumab, sold as Herceptin, for breast tumors that overexpress the HER2 protein. It was the first drug to attack a specific molecular target in breast cancer rather than poison dividing cells broadly. A once grim subtype became one of the more treatable ones.

Then

Patients with HER2-positive cancer gained a targeted option that worked where chemotherapy alone often failed.

Now

Herceptin proved that matching a drug to a tumor's biology could reset survival odds, opening the targeted-therapy era in cancer.

Why this matters now

Trodelvy follows the same logic for triple-negative disease: a drug aimed at a tumor protein, moved early to change the default treatment.

November 2020

Keytruda first-line TNBC approval (2020)

The FDA cleared Merck's Keytruda with chemotherapy as a first treatment for metastatic triple-negative breast cancer in tumors carrying the PD-L1 marker. It was the first immunotherapy approved for first-line use in this disease, based on the KEYNOTE-355 trial.

Then

PD-L1-positive patients gained an immune-based option at the start of treatment.

Now

It split triple-negative care by biomarker and set the stage for combination regimens like the new Trodelvy-plus-Keytruda pairing.

Why this matters now

The 2026 approval builds directly on this, adding Trodelvy to Keytruda for the same PD-L1-positive group.

August 2022

Enhertu HER2-low approval (2022)

The FDA approved trastuzumab deruxtecan, sold as Enhertu, for breast cancers with low HER2 levels once thought untreatable by HER2 drugs. The antibody-drug conjugate carried a chemotherapy payload straight to tumor cells. The DESTINY-Breast04 trial showed a survival gain.

Then

A large group of patients previously labeled HER2-negative gained access to a targeted drug.

Now

It cemented antibody-drug conjugates as a major breast cancer class and pushed makers to test them earlier.

Why this matters now

Trodelvy is the same kind of drug, an antibody-drug conjugate, and its first-line move reflects the wider shift toward using these earlier.

Sources

(10)
+4
U.S. Food and Drug Administration Gilead Sciences The ASCO Post CURE Business Wire OncLive U.S. Food and Drug Administration Gilead Sciences Gilead Sciences CURE Today