Sacituzumab govitecan-hziy

A pair of antibody-drug conjugate (ADC)-based breast cancer regimens are a step closer to European approval for some first-line indications.Gilead Sciences' Trodelvy (sacituzumab govitecan) secured its second first-line metastatic triple-negative breast cancer (TNBC) endorsement in Europe in the span of a month, with the EMA's Committee for Medicinal Products for Human Use (CHMP) recommending the TROP2-directed ADC together with Merck & Co.'s Keytruda (pembrolizumab) for patients whose tumours express PD-L1."If authorised, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status," said Evandro de Azambuja, investigator of the Phase III ASCENT-04/KEYNOTE-D19 study backing the latest recommendation.EU regulators had approved Trodelvy as a single agent last month in the frontline setting for metastatic TNBC based on data from the Phase III ASCENT-03 study, where it showed a 38% reduced risk of disease progression or death in patients who aren't candidates for PD-(L)1 inhibitors.In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% lower risk of disease progression or death in patients with PD-L1–positive metastatic TNBC. In more recent data presented at this year's American Society of Clinical Oncology (ASCO) meeting, the Trodelvy-Keytruda combo led to a 33% reduction in the risk of a progression-free survival 2 (PFS2) event versus Keytruda plus chemotherapy (see – KOL Views Q&A: Breast cancer at ASCO – first take on AZ and Roche oral SERD debates, Gilead's Trodelvy TNBC data and KOL Views Q&A: Gilead’s Trodelvy poised to redefine ADC sequencing in TNBC).A nod for EnhertuCHMP also adopted a positive opinion for AstraZeneca and Daiichi Sankyo's HER2-targeting ADC Enhertu (trastuzumab deruxtecan) in combination with Roche's Perjeta (pertuzumab) as a first-line treatment for HER2-positive metastatic breast cancer.The endorsement was backed by Phase III results from the DESTINY-Breast09 trial, where Enhertu-treated patients had a 44% lower risk of disease progression or death versus the current standard of taxane, Herceptin (trastuzumab) and Perjeta. Median PFS stood at 40.7 months for the doublet and 26.9 months for the comparator group.If approved, the regimen would become the first new first-line treatment option for HER2-positive metastatic breast cancer in the EU in more than a decade, according to AstraZeneca. The regimen was greenlit in this setting by the FDA late last year.

Approval marks an important advancement in the first-line treatment landscape and expands options for patients regardless of immunotherapy eligibility WASHINGTON, June 25, 2026 /PRNewswire/ -- Tigerlily Foundation welcomes the U.S. Food and Drug Administration's approval of Trodelvy® (sacituzumab govitecan-hziy) as a first-line treatment option for patients with metastatic triple-negative breast cancer (mTNBC), marking an important advancement for people living with one of the most aggressive forms of breast cancer. This approval has the potential to reshape the standard of care in the first-line metastatic TNBC setting by expanding access to an innovative treatment earlier in the disease course, when treatment decisions can have the greatest impact. For many patients with metastatic TNBC, the first treatment decision is especially important because more than half of patients may never receive a second or third line of therapy. "For women diagnosed with TNBC — and particularly women of color — this is a huge win," said Maimah Karmo, President and CEO of Tigerlily Foundation. "A first-line approval means more patients may have access to an effective treatment earlier, when it can make the most difference. For a disease that moves quickly and disproportionately impacts Black women, this kind of progress matters deeply." Why This Matters Triple-negative breast cancer is one of the most aggressive forms of breast cancer and disproportionately affects younger women and Black women. Black women are nearly three times more likely to be diagnosed with triple-negative breast cancer than white women. Among Black women diagnosed with breast cancer before age 40, approximately 50% have TNBC. In the metastatic setting, more than half of patients never receive a second or third line of therapy, making the first treatment decision especially important. Black women continue to face significant disparities in diagnosis, treatment, access to clinical trials, and outcomes. These realities underscore why access to the most effective therapies as early as possible can have a meaningful impact. For communities already facing barriers to timely diagnosis, comprehensive biomarker testing, clinical trial participation, and access to specialty care, approvals like this are important scientific milestones — but they must also be matched with real-world access. "This approval reflects years of scientific research, patient participation in clinical trials, and collaboration across the healthcare community," Karmo said. "But innovation only matters if patients can access it. Tigerlily will continue working to ensure that every patient — regardless of race, income, insurance status, or geography — has access to the latest evidence-based care." What Changed? Trodelvy is an antibody-drug conjugate, or ADC, a targeted cancer therapy designed to deliver chemotherapy directly to cancer cells expressing the Trop-2 protein while limiting exposure to healthy tissue. Clinical trials, including ASCENT-03 and ASCENT-04, demonstrated that using Trodelvy as an initial treatment: Reduced the risk of disease progression or death by 35% to 38% compared with standard chemotherapy. Nearly doubled the length of time many patients responded to treatment. Supported the use of Trodelvy earlier in the metastatic TNBC treatment journey. This approval moves Trodelvy from a later-line treatment option into the first-line metastatic setting, giving patients and clinicians another important therapy to consider at the beginning of treatment. What This Means for Standard of Care The FDA approval of Trodelvy in the first-line setting represents a meaningful shift in the treatment landscape for metastatic triple-negative breast cancer. Historically, first-line treatment options for mTNBC have often depended in part on a patient's PD-L1 status. PD-L1 is a biomarker that can help determine whether a patient may benefit from certain immunotherapy-based treatments. Patients with PD-L1 positive disease may be eligible for immunotherapy combinations, while patients whose tumors are PD-L1 negative — or who are not candidates for immunotherapy — have historically had fewer innovative first-line options. With this approval: Trodelvy can be used alone for patients who are not candidates for immunotherapy. Trodelvy can also be combined with Keytruda® for eligible patients with PD-L1 positive disease. This expands the first-line standard of care and provides clinicians with additional flexibility when developing treatment plans based on a patient's tumor biology, immunotherapy eligibility, overall health, treatment goals, and preferences. For patients, this means more people may have the opportunity to receive an advanced treatment option earlier in their metastatic breast cancer journey. This is especially meaningful because many people with mTNBC never reach later lines of therapy. Why PD-L1 Still Matters PD-L1 testing remains an important part of treatment planning for metastatic triple-negative breast cancer. It helps clinicians determine whether immunotherapy may be appropriate as part of a patient's first-line treatment plan. This approval does not eliminate the importance of PD-L1 testing. Instead, it broadens the treatment conversation. For eligible patients with PD-L1 positive disease, Trodelvy in combination with Keytruda may offer an important new first-line option. For patients who are PD-L1 negative or unable to receive immunotherapy, Trodelvy alone may provide a new treatment pathway where options have been limited. This is an important step toward more personalized care — ensuring that treatment decisions are guided by the biology of each patient's cancer, while also expanding access to innovation for more people living with metastatic TNBC. Advancing Health Equity in Breast Cancer Care Tigerlily Foundation recognizes this approval as both a scientific advancement and a health equity milestone. Triple-negative breast cancer has long reflected some of the most urgent inequities in breast cancer care. Black women are more likely to be diagnosed with TNBC, more likely to be diagnosed at younger ages, and more likely to experience delays in diagnosis and treatment. These disparities are shaped by systemic barriers, including unequal access to high-quality screening, timely diagnostic testing, biomarker testing, oncology specialists, clinical trials, and innovative therapies. For this approval to achieve its full promise, patients must be able to access: Timely and accurate diagnosis. Comprehensive biomarker testing, including PD-L1 testing when appropriate. Clear, culturally responsive patient education. Treatment from clinicians familiar with the latest mTNBC advances. Clinical trial information and enrollment opportunities. Insurance coverage and financial support for approved therapies. Patient navigation and support services throughout treatment. "Approvals like this are why representation in clinical trials matters," Karmo said. "Patients who participate in research help make progress possible for the next person facing a diagnosis. But we must ensure that communities most impacted by aggressive breast cancers are included in research, informed about new options, and able to access the care they deserve." Looking Ahead This approval represents meaningful progress in metastatic triple-negative breast cancer because many patients do not have the opportunity to receive second- or third-line therapy. Having an effective treatment option available in the first-line setting is a game changer. While more work remains to eliminate disparities and improve outcomes, advances like this provide new hope and underscore the importance of ensuring every patient has access to the latest evidence-based care. For Tigerlily Foundation President and CEO Maimah Karmo, the announcement carried profound personal significance. Exactly twenty years after being told she had breast cancer on February 28, 2006, at 4:44 p.m., Karmo learned of the FDA approval of Trodelvy at 4:44 p.m. once again. "For many people, 4:44 is simply a number," said Karmo. "For me, it has always been a reminder that even in life's darkest moments, we are never walking alone. Twenty years ago, 4:44 marked the moment my life changed forever. Twenty years later, at that very same time, I learned that people facing one of the most aggressive forms of breast cancer would have access to another life-extending treatment option. That moment reminded me that purpose can emerge from even our greatest challenges, and that every step forward in research brings new hope to patients and families everywhere." Since her diagnosis, Karmo has dedicated her career to ensuring that patients have a voice throughout every stage of the healthcare journey. Through Tigerlily Foundation, she has championed patient education, health equity, clinical trial awareness, research partnerships, and advocacy to help ensure that all patients have access to the latest advances in cancer care. "This approval is a testament to the patients who participated in clinical trials, the researchers and clinicians who pursued better treatments, and the advocates who continue pushing for progress," Karmo said. "While we celebrate this milestone, our work is not finished. Every patient deserves access to innovation, regardless of race, income, insurance status, or where they live." Tigerlily Foundation remains committed to advancing health equity by increasing awareness of clinical trials, expanding access to innovative treatments, reducing disparities in breast cancer care, and ensuring that patient voices remain at the center of research, policy, and healthcare decision-making. About Tigerlily Foundation Tigerlily Foundation is a national 501(c)(3) nonprofit organization dedicated to educating, advocating for, empowering, and supporting young women, women of color, and underserved communities before, during, and after breast cancer. Through patient navigation, health education, clinical trial advocacy, research partnerships, policy leadership, and community engagement, Tigerlily works to ensure that every person has equitable access to life-saving care and innovation. Media Contact Tigerlily Foundation Julie Annen Sr. Director, Health Literacy and Communications [email protected] SOURCE TIGERLILY FOUNDATION 21% more press release views with Request a Demo