In 2026, the FDA approved or expanded the use for several drugs for people with MBC. Read below to learn about these new approvals.
1. Gedatolisib (Revtorpyk®) for HR+, HER2- MBC
On July 14, 2026, the FDA approved gedatolisib (Revtorpyk®, Celcuity Inc.) with fulvestrant (Faslodex®), with or without palbociclib (Ibrance®), for the treatment of people with hormone receptor (HR)-positive, HER2-negative MBC without a PIK3CA mutation after their cancer came back or who completed at least one line of hormone therapy. This approval is based on results from the VIKTORIA-1 clinical trial.
- US Food and Drug Administration: FDA approves gedatolisib (Revtorpyk®) with fulvestrant (Faslodex®), with or without palbociclib (Ibrance®), for HR-positive, HER2-negative MBC
- Breastcancer.org: People with MBC who received gedatolisib (Revtorpyk®), fulvestrant (Faslodex®), and palbociclib (Ibrance®) lived longer without their cancer growing than people who did not receive all three drugs
- Metastatic Trial Search: Trials for gedatolisib (Revtorpyk®)
2. Camizestrant (Etcamah®) for HR+, HER2- MBC with an ESR1 Mutation
On September 4, 2026, the FDA granted accelerated approval to camizestrant (Etcamah®, AstraZeneca) plus a CDK4/6 inhibitor (abemaciclib (Verzenio®), palbociclib (Ibrance®), or ribociclib (Kisqali®)) and a companion diagnostic test for people with HR+, HER2- MBC with an ESR1?mutation that was detected while receiving an aromatase inhibitor (letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®)) and a CDK4/6 inhibitor. This approval is based on data from the SERENA-6 clinical trial.
- US Food and Drug Administration: FDA grants accelerated approval to camizestrant (Etcamah®) with a CDK4/6 inhibitor for ESR1-mutated HR+, HER2- MBC
- Breastcancer.org: FDA approves camizestrant (Etcamah®) for HR+, HER2- MBC
- Metastatic Trial Search: Trials for camizestrant (Etcamah®)
3. Vepdegestrant (Veppanu®) for ER+, HER2- MBC
On May 1, 2026, the FDA approved vepdegestrant (Veppanu®, Arvinas Operations, Inc.) and a companion diagnostic test for people with estrogen receptor-positive (ER+), HER2- MBC with an?ESR1 mutation whose cancer progressed after hormone therapy. This approval is based on data from the VERITAC-2 clinical trial.
- US Food and Drug Administration: FDA approves vepdegestrant (Veppanu®) for ER+, HER2- MBC with an ESR1 mutation
- Breastcancer.org: Vepdegestrant (Veppanu®) was approved by the FDA
4. Palbociclib (Ibrance®) Plus Trastuzumab (Herceptin®) With or Without Pertuzumab (Perjeta®) for HR+, HER2+ MBC
On June 24, 2026, the FDA approved palbociclib (Ibrance®) plus trastuzumab (Herceptin®) with or without pertuzumab (Perjeta®) and hormone therapy for people with HR+, HER2+ (triple-positive) MBC after treatment with taxane chemotherapy and trastuzumab, with or without pertuzumab. This approval is based on data from the PATINA clinical trial.
- US Food and Drug Administration: FDA approves palbociclib (Ibrance®) with trastuzumab (Herceptin®), with or without pertuzumab (Perjeta®), and hormone therapy for maintenance treatment of HR+, HER2+ MBC
- Metastatic Trial Search: Trials for palbociclib (Ibrance®)
5. Sacituzumab Govitecan-hziy (Trodelvy®) for Triple-Negative MBC
On June 24, 2026, the FDA added two approvals for sacituzumab govitecan-hziy (SG; Trodelvy®, Gilead Sciences, Inc.) for people with triple-negative MBC. The first use is for SG alone as first-line treatment in people who cannot receive immunotherapy drugs that inhibit PD-1 or PD-L1. This approval is based on data from the ASCENT-03 clinical trial.
The second use is for SG plus pembrolizumab (Keytruda®) as first-line treatment in people whose tumors express PD-L1. This approval is supported by the ASCENT-04/KEYNOTE D-19 trial.
- US Food and Drug Administration: FDA approves sacituzumab govitecan-hziy (Trodelvy®) alone and in combination with pembrolizumab (Keytruda®) for first-line treatment of triple-negative MBC
- Metastatic Trial Search: Trials for sacituzumab govitecan-hziy (Trodelvy®)
6. Datopotamab deruxtecan-dlnk (Datroway®) for Triple-Negative MBC
On May 22, 2026, the FDA expanded its approval for datopotamab deruxtecan-dlnk (Datroway®, Daiichi Sankyo, Inc.). This antibody-drug conjugate is now approved for people with triple-negative MBC who cannot receive PD-1 or PD-L1 inhibitor therapy. This approval is based on data from the TROPION-Breast02 clinical trial.
- US Food and Drug Administration: FDA approves datopotamab deruxtecan-dlnk (Datroway®) for triple-negative MBC
- Metastatic Trial Search: Trials for datopotamab deruxtecan-dlnk (Datroway®)
Last Modified on October 1, 2026